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Bicalutamide - 0378-7017-05 - (bicalutamide)

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Drug Information of Bicalutamide

Product NDC: 0378-7017
Proprietary Name: Bicalutamide
Non Proprietary Name: bicalutamide
Active Ingredient(s): 50    mg/1 & nbsp;   bicalutamide
Administration Route(s): ORAL
Dosage Form(s): TABLET, FILM COATED
Coding System: National Drug Codes(NDC)

Labeler Information of Bicalutamide

Product NDC: 0378-7017
Labeler Name: Mylan Pharmaceuticals Inc
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA079185
Marketing Category: ANDA
Start Marketing Date: 20120822

Package Information of Bicalutamide

Package NDC: 0378-7017-05
Package Description: 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7017-05)

NDC Information of Bicalutamide

NDC Code 0378-7017-05
Proprietary Name Bicalutamide
Package Description 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-7017-05)
Product NDC 0378-7017
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name bicalutamide
Dosage Form Name TABLET, FILM COATED
Route Name ORAL
Start Marketing Date 20120822
Marketing Category Name ANDA
Labeler Name Mylan Pharmaceuticals Inc
Substance Name BICALUTAMIDE
Strength Number 50
Strength Unit mg/1
Pharmaceutical Classes Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]

Complete Information of Bicalutamide


General Information