Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 091011
Company: KENTON
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/10/2015 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/091011Orig1s000ltr.pdf

BICALUTAMIDE

TABLET;ORAL; 50MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 078917 ACCORD HLTHCARE
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 200274 APOTEX INC
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079045 FRESENIUS KABI USA
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 091011 KENTON
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079185 MYLAN
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 078575 SANDOZ
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079110 SUN PHARM
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 076932 TEVA
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 078634 WATSON LABS TEVA
BICALUTAMIDE BICALUTAMIDE 50MG TABLET;ORAL Prescription No AB 079089 ZYDUS PHARMS USA INC
CASODEX BICALUTAMIDE 50MG TABLET;ORAL Prescription Yes AB 020498 ANI PHARMS INC

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