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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078917
Company: ACCORD HLTHCARE
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
07/06/2009 ORIG-1 Approval Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078917s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078917s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/30/2018 SUPPL-10 Labeling-Package Insert

Label is not available on this site.

12/30/2018 SUPPL-7 Labeling-Package Insert

Label is not available on this site.

05/10/2016 SUPPL-6 Labeling-Package Insert

Label is not available on this site.

07/20/2012 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

11/02/2011 SUPPL-2 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/15/2009 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/06/2009 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/078917s000lbl.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 091011 KENTON
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 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
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