CYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC]

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CYCLOSERINE CAPSULE [PURDUE GMP CENTER LLC]
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NDC 13845-1202-2
Set ID 0071f9f3-a29b-4ba6-9555-69f672501cbc
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Parsolex Gmp Center, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA060593
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  • Blister Labeling

    Panels for the blister pack carton

  • Blister Pack Carton

    Panels for the blister pack carton

    CycloSERINE

    rege

  • INGREDIENTS AND APPEARANCE
    CYCLOSERINE 
    cycloserine capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:13845-1202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CYCLOSERINE (UNII: 95IK5KI84Z) (CYCLOSERINE - UNII:95IK5KI84Z) CYCLOSERINE250 
    Product Characteristics
    Colorred, grayScoreno score
    Shapecapsule (CHAO F04) Size20mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13845-1202-230 in 1 CARTON01/29/1952
    130 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06059301/29/1952
    Labeler - Parsolex Gmp Center, Inc. (159802532)
    Registrant - Parsolex Gmp Center, Inc. (159802532)
    Establishment
    NameAddressID/FEIBusiness Operations
    Parsolex Gmp Center, Inc.159802532manufacture(13845-1202)
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