Finasteride tablets  is  indicated  for  the  treatment  of  male  pattern  hair  loss  (androgenetic  alopecia)  in  MEN ONLY.

Efficacy in bitemporal recession has not been established.

Finasteride tablets is not indicated  for use in women.

Finasteride tablets, USP may be administered  with or without meals.

The recommended  dose of finasteride tablets, USP is  one tablet (1 mg) taken once daily.

In  general,  daily  use  for  three months or more is  necessary before benefit is  observed. Continued use is recommended  to  sustain  benefit,  which  should  be  re-ev aluated  periodically.  Withdrawal  of  treatment leads to reversal of effect within 12 months.

Finasteride tablets, USP are  reddish brown colored, 7 mm round, biconvex, film coated tablets, marked “F1” on one side and plain on other side.

Finasteride tablets is contraindicated  in the following:

• Pregnancy. Finasteride use is contraindicated  in  women  when  they  are  or may  potentially  be pregnant.  Because of the ability of Type II 5α-reductase inhibitors to inhibit the conversion of testosterone  to  5 α-dihydrotestosterone  (DHT),  finasteride  may cause abnormalities of the external genitalia  of  a  male fetus  of a pregnant woman who receives finasteride. If  this drug is used during pregnancy,  or  if  pregnancy  occurs  while  taking  t his  drug,  the  pregnant  woman  should be apprised of the  potential  hazard  to  the  male  fetus.   [ See   Warnings   and   Precautions    (5.1),  Use  in  Specific  Populations   (8.1),  How   Supplied / Storage   and   Handling   ( 16 )   and   Patient    Counseling   Infor mation  (17.1).]   In   female   rats,   low   doses   of   finast eride  administered  during  pregnancy  have  produced  abnormalities   of  the  external  genitalia   in  male  offspring.
• Hypersensitivity   to  any  component   of  this  medication.

7.1 Cytochrome P450-Linked Drug Metabolizing Enzyme System

No drug interactions of clinical importance have been identified. Finasteride does not appear to affect the cytochrome P450-linked drug-metabolizing enzyme system. Compounds that have been tested in man include antipyrine, digoxin, propranolol, theophylline, and warfarinand no clinically meaningful interactions were found.

7.2 Other Concomitant Therapy

Although specific interaction studies were not performed, finasteride doses of 1 mg or more were concomitantly used in clinical studies with acetaminophen, acetylsalicylic acid, α-blockers, analgesics, angiotensin-converting enzyme (ACE) inhibitors, anticonvulsants, benzodiazepines, beta blockers, calcium-channel blockers, cardiac nitrates, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, prostaglandin synthetase inhibitors (also referred to as NSAIDs), and quinolone anti-infectives without evidence of clinically significant adverse interactions.

In clinical studies, single doses of finasteride up to 400 mg and multiple doses of finasteride up to 80 mg/day for three months did not result in adverse reactions. Until further experience is obtained, no specific treatment for an overdose with finasteride can be recommended.

Significant lethality was observed in male and female mice at single oral doses of 1500 mg/ m2 (500 mg/kg) and in female and male rats at single oral doses of 2360 mg/ m2(400 mg/kg) and 5900 mg/m2 (1000 mg/kg), respectively.

Finasteride Tablets, USP contain  finasteride  as  the  active  ingredient.  Finasteride,  a  synthetic 4-azasteroid  compound,  is  a  spe cific  inhibitor  of  steroid  Type  II  5α-reductase,  an  intracellular  enzyme that converts the androgen  testosterone into 5α-dihydrotestosterone (DHT).

The chemical name of finasteride is N-ter t-But yl-3-o xo-4-aza-5 α-androst-1-ene-17β-carboxamide. The empirical formula of finasteride is C23H36N2O2 and its molecular weight is 372.55. Its structural formula is:

Finasteride  is  a  white  crystalline  powder  with  a  melting  point  near  250°C.  It  is  freely  soluble in  chloroform and in lower alcohol solvents but is practically insoluble  in water.

Finasteride Tablets, USP is   film-coated  tablets  for  oral  administra tion.  Each  tablet  contains  1 mg of  finasteride  and  the  following  inactive  ingredients: lactose  monohydrate,  microcrystalline cellulose, pregelatinized  starch,  sodium  starch  glycolate, lauroylmacrogol 32 glycerides, magnesium stearate, Hypromellose, Titanium Dioxide,  polyethylene glycol, Iron Oxide Red, and Iron Oxide Yellow.

14.1 Studies in Men

The  efficacy  of  finasteride tablets  was  demonstrated  in men  (88%  Caucasian) with  mild  to  moderate androgenetic  alopecia  (male  pattern  hair  loss)  between  18  and  41 years of  age. In  order to  prevent seborrheic  dermatitis  which  might  confound  the  assess ment  of  hair growth in these studies, all men, whether  treated  with finasteride or placebo, were i nstructed  to  use a  specified, medicated, tar-based shampoo (Neutrogena T/Gel® Shampoo) during  the first 2 years of the studies.

There  were  three  double-blind,  randomized,  placebo- controlled  studies  of  12-month  duration.  The two primary endpoints were hair count and patient self-assessment; the two secondary endpoints were investigator  assessment  and  ratings  of  photographs.  In addition, information was collected regarding sexual  function  (based  on  a self-administered que stionnaire) and non-scalp body hair growth. The three studies  were  conducted  in  1879  men  with  mild  to   moderate,  but  not  complete,  hair  loss.  Two  of  the studies  enrolled  men  with  predominantly  mild  to  moderate  vertex  hair  loss  (n=1553). The third enrolled men  having  mild  to  moderate  hair  loss  in  the  anterior  mid-scalp  area with or without vertex balding (n=326).

Studies in Men with Vertex Baldness 

Of  the  men  who  completed  the  first  12  months  of  the  two  vertex  baldness  trials,  1215  elected  to  continue in double-blind, placebo-controlled, 12-month e xtension studies. There were 547 men receiving finasteride tablets for  both  the  initial  study  and  first  extension  periods  (up  to  2  years  of treatment) and 60 men receiving  placebo  for  the  same  periods.  The  extension  studies  were  continued  for  3  additional  years,  with 323 men on finasteride tablets and 23 on placebo ente ring  the fifth year of the study.

In  order  to  evaluate  the  effect  of  discontinuation  of therapy, there  were 65 men who received finasteride tablets for  the  initial  12  months  followed  by  placebo  in  the first 12-month extension period. Some of these men continued  in  additional  extension  studies  and  were  s witched  back to treatment with finasteride tablets with 32 men  entering  the  fifth  year  of  the  study.  Lastly, there were 543 men who received placebo for the initial 12 months  followed  by  finasteride tablets  in the first 12-month extension period. Some of these men continued in additional  extension  studies  receiving  finasteride tablets  with  290  men  entering  the  fifth  year  of the study (see Figure 1 below).

Hair counts were assessed by photog raphic enlargements of a representati ve area of active hair loss. In these two studies in men with vertex baldness, signif icant increases in hair count were demonstrated at 6 and  12  months in men  treated  with finasteride tablets, while significant hair loss from  baseline  was demonstrated  in  those  treated  with placebo. At 12 months there was a 107-hair difference from placebo (p<0.001,  finasteride tablets  [n=679]  vs  placebo  [n=672])  within  a  1-inch  diameter  circle  (5.1  cm2).  Hair  count was  maintained  in  those  men  taking  finasteride tablets  for  up  to  2  years,  resulting  in  a  138-hair  difference between  treatment  groups  (p<0.001,  finasteride tablets  [n=433]  vs  placebo  [n=47])  within  the  same  area.  In men  treated  with  finasteride tablets  the  maximum  impro vement  in  hair  count  compared  to  baseline was achieved  during  the  first 2 years. Although the initial improvement was followed by a slow decline, hair count  was  maintained  above  baseline  throughout the 5 years of the studies. Furthermore, because the decline  in  the  placebo  group  was  more  rapid,  the  difference  between  treatment  groups  also  continued  to increase  throughout  the  studies,  resulting  in  a  277 -hair  difference  (p<0.001,  finasteride tablets [n=219] vs placebo [n=15]) at 5 years (see Figure 1 below).

Patients  who  switched  from  placebo  to  finasteride tablets  (n =425)  had a decrease in hair count at the end of the initial  12-month  placebo period, followed by an increase in hair count after 1 year of treatment with finasteride tablets.  This  increase  in hair count was less (56 hairs above original baseline) than the increase (91 hairs above original baseline) observed after  1 year of treatment in men initially randomized to finasteride tablets.  Although  the  increase  in  hair  count,  relative  to  when therapy was initiated, was comparable between  these  two  groups,  a  higher  absolute hair count  was achieved in patients who were started on treatment  with  finasteride tablets in the initial study.  This advantage was maintained through the remaining 3 years  of  the  studies.  A  change  of  treatment  from  finasteride tablets  to  placebo  (n=48) at the end of the initial 12 months  resulted  in  reversal  of  the  increase  in  hair  count  12  months  later,  at  24  months (see Figure 1 below).

At  12  months,  58%  of  men in the placebo group had f urther hair loss (defined as any decrease in hair count  from  baseline),  compared  with  14%  of  men  treated  with  finasteride tablets.  In  men  treated  for  up  to  2 years,  72%  of  men in the pla cebo group demonstrated hair loss, compa red with 17% of men treated with finasteride tablets.  At  5  years,  100%  of  men  in  the  p lacebo  group  demonstrated  hair  loss,  compared  with  35% of men treated with finasteride tablets.

Figure 1

Patient  self-assessment  was  obtained  at  each  clinic  visit  from  a  self-administered questionnaire, which included  questions on  their  perception of  hair growth,  hair loss,  and appearance. This  self-assessment demonstrated  an  increase  in  amount  of  hair,  a  dec rease  in  hair loss,  and  improvement in  appearance in men  treated  with  finasteride tablets.  Overall  improvement  compared  with  placebo  was  seen  as  early  as  3 months (p<0.05), with improve ment maintained  over 5 years.

Investigator  assessment  was  based  on  a 7-point scale e valuating increases or decreases in scalp hair at each  patient  visit.  This  assessment  showed  significantly  greater  increases  in hair growth in men treated with  finasteride tablets  compared  with placebo as early as 3 months (p<0.001). At 12 months, the investigators rated  65%  of  men  treated  with finasteride tablets as having increased hair growth compared with 37% in the placebo  group.  At  2 years, the investigators rated 80% of men treated with finasteride tablets as having increased  hair  growth  compared  with  47%  of  men  treated  with  placebo.  At  5  years,  the investigators rated 77%  of  men  treated  with  finasteride tablets  as having inc reased hair growth, compared with 15% of men treated with placebo.

An  independent  panel  rated  standardized  photographs  of  the  head  in  a blinded fashion based on increases  or  decreases  in  scalp  hair  using  the  same  7-point scale as the investigator assessment. At 12 months,  48%  of  men  treated  with  finasteride tablets mg had an increase as compared with 7% of men treated with placebo.  At 2 years, an increase in hair growth was demonstrated in 66% of men treated with finasteride tablets,  compared with 7% of men treated with placebo. At 5 years, 48% of men treated with finasteride tablets  demonstrated  an  increase in hair growth, 42% were rated as having no change (no further visible  progression  of  hair  loss  from  baseline)  and  10% were  rated  as  having  lost  hair  when  compared  to baseline.  In  comparison, 6%  of  men  treated  with  placebo  demonstrated  an  increase  in  hair  growth,  19% were rated as having no change and 75% were rated as  having lost hair when compared to baseline.

A  48-week,  placebo-controlled  study  designed to assess  by phototrichogram the effect of finasteride tablets on total  and  actively  growing  (anagen)  scalp  hairs  in  vertex  baldness  enrolled  212  men  with androgenetic alopecia.  At  baseline  and  48  weeks,  total  and  anagen  hair  counts  were  obtained  in  a  1-cm2 target  area  of the  scalp.  Men  treated  with  finasteride tablets  showed  increases  from  baseline  in  total  and  anagen  hair  counts of  7  hairs  and  18  hairs,  respectively,  whereas  men  treated  with  placebo  had decreases of 10 hairs and 9 hairs,  respectively.  These  changes  in  hair  counts  resulted  in  a  between-group  difference  of  17  hairs  in total  hair count (p<0.001) and 27 hairs in anagen hair count (p<0.001), and an improvement in the proportion of anagen hairs from 62% at basel ine to 68% for men treated with finasteride tablets.

Other Results in Vertex Baldness Studies 

A  sexual function questionnaire was self-administered  by patients participating in the two vertex baldness trials  to  detect  more subtle changes in  sexual function. At Month 12, statistically significant differences in favor of placebo were found in 3 of 4 domains (se xual interest, erections, and perception of sexual problems).  However,  no  significant  difference  was   seen  in  the  question  on  overall  satisfaction  with  sex life.

In  one  of  the  two  vertex  baldness  studies,  patients  were  questioned  on  non-scalp  body  hair growth. finasteride tablets did not appear  to affect non-scalp  body hair.

Study  in Men with Hair Loss in the Anterior Mid-Scalp Area 

A  study  of  12-month  duration,  designed  to  assess  the  efficacy  of  finasteride tablets in men with hair loss in the anterior  mid-scalp  area,  also  demonstrated significant increases in hair count compared with placebo. Increases  in  hair  count  were  accompanied  by  imp rovements  in  patient sel f-assessment, investigator assessment,  and  ratings  based  on standardized photograph s. Hair counts were obtained in the anterior mid-scalp area, and did not include the area of b itemporal recession or the anterior hairline.

Summary  of Clinical Studies in Men 

Clinical  studies  were  conducted  in  men  aged  18  to  41  with  mild  to  moderate  degrees  of  androgenetic alopecia.  All  men  treated  with  finasteride tablets or  placebo  received  a  tar-based  shampoo  (Neutrogena T/Gel® Shampoo)  during  the  first  2  years  of  the  studies. Clini cal improvement was seen as early as 3 months in the  patients  treated  with  finasteride tablets  and  led  to  a  net increase  in  scalp  hair  count  and  hair  regrowth.  In clinical  studies for up to 5 years, treatment with  finasteride tablets slowed the further progression of hair loss observed in the placebo group.  In general, the difference between treatment groups continued to increase throughout the 5 years of the studies.

Ethnic Anal ysis of Clinical Data from Men 

In  a  combined analysis of the two studies on ver tex baldness, mean hair count changes from baseline were  91 vs -19  hairs  (Finasteride tablets  vs  placebo)  among  Caucasians  (n=1185),  49 vs -27  hairs  among Blacks  (n=84),  53 vs -38  hairs among Asians ( n=17), 67 vs 5 hairs  among  Hispanics (n=45) and 67 vs -15  hairs  among  other  ethnic  groups  (n=20).  Patient  self-assessment  showed  improvement  across racial  groups  with  finasteride tablets  treatment,  except  for  satisfaction  of  the  frontal  hairline  and  vertex  in Black men, who were satisfied overall.

14.2 Study in Women

In  a  study  involving  137  postmenopausal  women  with  androgenetic  alopecia who were treated with finasteride tablets  (n=67)  or  placebo  (n=70)  for  12  month s,  effectiveness  could  not be demonstrated. There was no  improvement  in  hair  counts,  patient  self-assessment,  investigator  assessment,  or ratings of standardized  photographs  in  the  women  treated  with  finasteride tablets  when compared with the placebo group[see Indications and Usage (1)].

Finasteride tablets, USP 1 mg are available as  reddish brown colored, 7 mm round, biconvex, film-coated tablets, marked “F1” on one side and plain on other side. They are supplied  as follows:

30’s HDPE Container pack: NDC 67877-455-30

90’s HDPE Container pack: NDC 67877-455-90

500’s HDPE Container pack: NDC 67877-455-05

30 (3 x 10) Unit Dose Tablets (Alu-PVC/PVDC Pack): NDC 67877-455-94

Storage and Handling 

Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Preserve in a tight, light-resistant container

Women  should  not  handle crushed or broken Finasteride Tablets when they are pregnant or may potentially be pregnant  because  of the possibility of absorption of finasteride and the subsequent potential  risk  to  a  male  fetus.  Finasteride Tablets, USP 1 mg are  coated  and  will  prevent  contact  with  the  active ingredient  during normal handling, provided that the tablets are not broken or crushed [ see  Warnings  and  Precautions  (5.1),  Use  in  Specific  Populations   (8.1)and Patient  Counseling  Infor mation  (17.1)] .

See FDA-approved patient labeling (Patient Information).

17.1 Exposure of Women — Risk to Male Fetus

Physicians  should  inform  patients  that  women  who  are  pregnant  or  may  potentially  be  pregnant  should not  handle  crushed  or  broken  finasteride tablets  because  of  the  possibility  of  absorption  of  finasteride and  the  subsequent  potential  risk  to  a  male  fetus.  Finasteride tablets are coated and will prevent contact with  the  active  ingredient  during  normal  handling,  provided that the table ts  have not  been broken or crushed.  If  a  woman  who  is  pregnant  or  may  potenti ally  be pregnant comes in contact with crushed or broken  finasteride tablets,  the  contact  area   should  be  washed  immediately  with  soap  and  water [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1) and How Supplied/Storage and Handling (16)].

17.2 Increased Risk of High-Grade Prostate Cancer

Patients should be informed that there was an increase in high-grade prostate cancer in men treated with 5α-reductase inhibitors indicated for BPH treatment, compared to those treated with placebo in studies looking at the use of these drugs to prevent prostate cancer [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)].

17.3 Additional Instructions

Physicians  should  instruct  their  patients  to  promptly  report  any  changes  in  their  breasts  such  as  lumps, pain  or  nipple  discharge.  Breast  changes  including  breast  enlargement,  tenderness  and  neoplasm  have been  reported [see Adverse Reactions (6.1)].

Physicians should instruct their patients to read the patient package insert be fore starting therapy with finasteride tablets and to read it again each time the prescript ion is renewed so that they are aware of current information for patients regarding  finasteride tablets.

The trademarks depicted herein are owned by their respective companies.

Manufactured by:

Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: January 2017

PT 2307-01

Finasteride Tablets, USP
(fin NAH steh ride)

Finasteride tablets, USP is for use by MEN ONLY and should NOT be used by women or children.

Read  this  Patient  Information  before  you  start  taking  finasteride tablets, USP and  each  time  you  get  a  refill.  There may  be  new  information.  This  information  does not take the place of talking with your healthcare provider about your medical condition or treatment.

What is finasteride tablets, USP? 

Finasteride tablets, USP is  a  prescription  medicine  used  for  the  treatment  of  male  pattern  hair  loss  (androgenetic alopecia).

It  is  not  known  if  finasteride tablets, USP works  for  a  reced ing  hairline  on  either  side  of  and  above  your  forehead (temporal area).

Finasteride tablets, USP is not for use by   women and children.

Who should not take finasteride tablets, USP? 

Do not take finasteride tablets, USP if you: 

·                are pregnant or may become pregnant. Finasteride Tablets, USP 1 mg may harm your unborn baby.

o      Finasteride tablets, USP are coated and will prevent  contact with the medicine during handling, as  long  as  the  tablets  are  not  broken  or crushed. Females who are pregnant or who may become pregnant should not come in contact with broken or crushed finasteride tablets, USP. If  a  pregnant  woman  comes  in  contact  with c rushed or broken finasteride tablets, USP, wash the  contact  area  right  away  with  soap  and  w ater.  If  a  woman who is pregnant comes into contact  with the active ingredient in  finasteride tablets, USP, a healthcare provider should be consulted.

o      If  a  woman  who  is  pregnant  with  a  male  baby  swallows  or  comes  in  contact  with  the medicine in finasteride tablets, USP, the male baby may be  born with sex organs that are not normal.

·                are  allergic  to  any  of  the  ingredients  in  finasteride tablets, USP.  See  the  end  of  this  leaflet  for  a  complete  list of ingredients in finasteride tablets, USP.

What should I tell my  healthcare pro vider before taking finasteride tablets, USP?

Before taking finasteride tablets, USP,  tell your healthcare provider if you:

·                have any other medical conditions, including  problems with your prostate or liver

Tell   your  healthcare  pro vider  about  all  the  medicines   you  take,  including  prescription  and  non- prescription medicines, vitamins, and herbal supplements.

Know  the  medicines  you  take.  Keep  a  list  of  them  to  show  your  healthcare  provider  and  pharmacist  when you get a new medicine.

How  should I take finasteride tablets, USP? 

·                Take finasteride tablets, USP exactly as your healt hcare provider tells you to take it.

·                You may take finasteride tablets, USP with or without food.

·                If you forget to ta ke finasteride tablets, USP, do not take an extra tablet. Just take the next tablet as usual. 

Finasteride tablets, USP will not  work faster or better if you take it more than once a day.

What are the possible side effects of Finasteride tablets, USP? 

·                decrease  in   your  blood  Prostate  Specific  Antigen  (PSA)  le vels.  Finasteride tablets, USP  can  affect  a  blood test  called  PSA  (Prostate-Specific  Antigen)  for  the  screening  of  prostate  cancer.  If  you  have  a PSA  test  done  you  should  tell  your  healthcare  pro vider  that you are taking finasteride tablets, USP because finasteride tablets, USP decreases  PSA  level s.  Changes  in PSA levels will need to be evaluated by your healthcare  provider.  Any  increase  in  follow-up  PSA  l evels  from  their lowest point may signal the presence of prostate cancer and should be evaluated, even if the test results are still within the normal  range  for  men  not  taking  finasteride tablets, USP.  You  should  also  tell your healthcare provider if you have  not  been  taking  finasteride tablets, USP  as  prescribed  because  this  may  affect  the  PSA  test  results. For more information, talk to your healthcare provider.

·                There may be an increased  risk  of a  more  serious form  of  prostate  cancer  in  men taking finasteride at 5 times the dose of finasteride tablets, USP.

The most common side effects of finasteride tablets, USP include:

·                decrease in sex drive

·                trouble getting or keeping an erection

·                a decrease in the amount of semen

The following have been reported in general use with finasteride tablets, USP:

·                breast  tenderness  and  enlargement.  Tell  your  healt hcare  provider  about  any  changes  in  your breasts such as lumps, pain or nipple discharge.

·                depression;

·                decrease in sex drive that con tinued after stopping the medication;

·                allergic reactions including rash, itching, hiv es and swelling of the lips, tongue, throat, and face;

·                problems with ejaculation that continued after stopping medication;

·                testicular pain;

·                difficulty in achieving an erection that continued after stopping the medication;

·                male infertility and/or poor quality of semen.

·                in rare cases, male breast cancer.

Tell your healthcare provider if you have any side  effect that bothers you or that does not go away.

These  are  not  all  the  possible  side  effects  of  finasteride tablets, USP.  For  more  information,  ask  your  healthcare provider or pharmacist.

Call  your  doctor  for  medical  advice  about  side  effects.  You  may  report  side  effects  to  FDA  at  1-800-FDA-1088.

How  should I store Finasteride Tablets, USP 1 mg? 

·                Store finasteride tablets, USP at room temperature between 68˚F to 77˚F (20˚C to 25˚C).

·                Keep Finasteride Tablets, USP 1 mg  in a  closed container  and  keep finasteride tablets, USP  dry (protect from moisture).

Keep finasteride tablets, USP and all medici nes out of the reach of children.

General information about the safe and effecti ve use of finasteride tablets, USP. 

Medicines  are  sometimes  prescribed  for  purposes  other  than  those  listed  in  this  Patient  Information leaflet.  Do  not  use finasteride tablets, USP for a condition for which it was not prescribed. Do not give finasteride tablets, USP to other people, even if they have the same  symptoms you have. It may harm them.

This  Patient  Information  leaflet  summarizes  the  most  important  information  about  finasteride tablets, USP.  If  you would like more information, talk with your  healthcare  provider. You  can ask  your pharmacist or healthcare  provider  for  information  about  finasteride tablets, USP that  is  written  for  health  professionals. For more information go to http://www.ascendlaboratories.com or call 1-877-ASC-RX01 (877-272-7901).

What are the ingredients in finasteride tablets, USP? 

Active ingredient: Finasteride, USP

Inactive ingredients: lactose  monohydrate,  microcrystalline cellulose, pregelatinized  starch,  sodium  starch  glycolate, lauroylmacrogol 32 glycerides, magnesium stearate, hypromellose, titanium dioxide,  polyethylene glycol, iron oxide red, and iron oxide yellow.

This Patient Information has been approved by the U.S. Food and Drug Administration. 

Manufactured by:

Alkem Laboratories Ltd.

Mumbai - 400 013, INDIA

Distributed by:

Ascend Laboratories, LLC

Parsippany, NJ 07054

Revised: January 2017

PT 2328-01

FINASTERIDE TABLETS, USP 1 MG
Warning: Finasteride Tablets, USP 1 mg should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP 1 mg. They should also not handle crushed or broken tablets of Finasteride Tablets, USP 1 mg. (See Package Insert.)
Rx only
30 Tablets

FINASTERIDE TABLETS, USP 1 MG
Warning: Finasteride Tablets, USP 1 mg should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP 1 mg. They should also not handle crushed or broken tablets of Finasteride Tablets, USP 1 mg. (See Package Insert.)
Rx only
90 Tablets

FINASTERIDE TABLETS, USP 1 MG
Warning: Finasteride Tablets, USP 1 mg should not be used by women or children. Women who are or may potentially be pregnant must not use Finasteride Tablets, USP 1 mg. They should also not handle crushed or broken tablets of Finasteride Tablets, USP 1 mg. (See Package Insert.)
Rx only
500 Tablets