EXEMESTANE TABLET [CADILA HEALTHCARE LIMITED]

EXEMESTANE TABLET [CADILA HEALTHCARE LIMITED]
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NDC	70771-1374-3
Set ID	fab5468a-d5b7-45e3-b8b2-ed902fddd3a6
Category	HUMAN PRESCRIPTION DRUG LABEL
Packager	Cadila Healthcare Limited
Generic Name
Product Class	Aromatase Inhibitor
Product Number
Application Number	ANDA202602

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SPL UNCLASSIFIED SECTION
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1374-3 in bottle of 30 tablets

Exemestane Tablets, 25 mg

Rx only

30 tablets

INGREDIENTS AND APPEARANCE

EXEMESTANE
exemestane tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC:70771-1374
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EXEMESTANE (UNII: NY22HMQ4BX) (EXEMESTANE - UNII:NY22HMQ4BX)	EXEMESTANE	25 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
MAGNESIUM CARBONATE (UNII: 0E53J927NA)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSPOVIDONE (UNII: 2S7830E561)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)

Product Characteristics
Color	WHITE (WHITE)	Score	no score
Shape	ROUND (ROUND)	Size	6mm
Flavor		Imprint Code	383
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70771-1374-3	30 in 1 BOTTLE; Type 0: Not a Combination Product	10/08/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202602	10/08/2018

Labeler - Cadila Healthcare Limited (918596198)

Registrant - Cadila Healthcare Limited (863362789)

Name	Address	ID/FEI	Business Operations
Establishment
Cadila Healthcare Limited		863362789	ANALYSIS(70771-1374) , MANUFACTURE(70771-1374)

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