Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP)
Zydus Lifesciences Limited
BICALUTAMIDE
BICALUTAMIDE 50 mg
ORAL
PRESCRIPTION DRUG
Bicalutamide tablets 50 mg daily is indicated for use in combination therapy with a luteinizing hormone-releasing hormone (LHRH) analog for the treatment of Stage D2 metastatic carcinoma of the prostate. Bicalutamide tablets 150 mg daily is not approved for use alone or with other treatments [see Clinical Studies (14.2)]. Bicalutamide is contraindicated in: Hypersensitivity Bicalutamide is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or any of the tablet's components. Hypersensitivity reactions including angioneurotic edema and urticaria have been reported. Women Bicalutamide has no indication for women, and should not be used in this population. Pregnancy Bicalutamide can cause fetal harm when administered to a pregnant woman. [see Use in Specific Populations (8.1) ]. Risk Summary Bicalutamide is contraindicated for use in pregnant women because it can cause fetal harm. Bicalutamide is not indicated for use in females. There are no human data on the use of bicalutam
Bicalutamide Tablets USP, 50 mg are white to off-white, round, biconvex, film-coated tablets, debossed with ZE 57 on one side and plain on other side and are supplied as follows: NDC 65841-613-06 in bottle of 30 tablets NDC 65841-613-01 in bottle of 100 tablets NDC 65841-613-05 in bottle of 500 tablets NDC 65841-613-10 in bottle of 1000 tablets NDC 65841-613-77 in cartons of 100 tablets (10 x 10 unit-dose) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container.
Abbreviated New Drug Application
BICALUTAMIDE - BICALUTAMIDE TABLET, FILM COATED ZYDUS LIFESCIENCES LIMITED ---------- BICALUTAMIDE TABLETS PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-613-06 in bottle of 30 tablets Bicalutamide Tablets USP, 50 mg R only 30 tablets BICALUTAMIDE bicalutamide tablet, film coated PRODUCT INFORMATION PRODUCT TYPE HUMAN PRESCRIPTION DRUG ITEM CODE (SOURCE) NDC:65841-613 x ROUTE OF ADMINISTRATION ORAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH BICALUTAMIDE (UNII: A0Z3NAU9DP) (BICALUTAMIDE - UNII:A0Z3NAU9DP) BICALUTAMIDE 50 mg INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PRODUCT CHARACTERISTICS COLOR WHITE (WHITE TO OFF- WHITE) SCORE no score SHAPE ROUND (ROUND) SIZE 6mm FLAVOR IMPRINT CODE Z E;57 CONTAINS PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:65841- 613-06 30 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 2 NDC:65841- 613-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 3 NDC:65841- 613-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 4 NDC:65841- 613-10 1000 in 1 BOTTLE; Type 0: Not a Combination Product 07/06/2009 5 NDC:65841- 613-30 10 in 1 CARTON 07/06/2009 5 10 in 1 BLISTER PACK; Type 0: Not a Combination Product MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE ANDA ANDA079089 07/06/2009 LABELER - Zydus Lifesciences Limited (918596198) Zydus Lifesciences Limited REGISTRANT - Zydus Lifesciences Limited (918596198) ESTABLISHMENT NAME ADDRESS ID/FEI BUSINESS OPERATIONS Zydus Lifesciences Limited 918596198 ANALYSIS(65841-613) , MANUFACTURE(65841-613) Revised: 10/2022 Baca dokumen lengkapnya