Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078634
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
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 |
---|---|---|---|---|---|---|---|
08/28/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/07/2019 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2016 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
05/10/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/14/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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 | 079089 | ADAPTIS |
BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 200274 | APOTEX |
BICALUTAMIDE | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | No | AB | 091011 | CHARTWELL RX |
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 |
CASODEX | BICALUTAMIDE | 50MG | TABLET;ORAL | Prescription | Yes | AB | 020498 | ANI PHARMS |