Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075659
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AFEDITAB CR | NIFEDIPINE | 60MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 10/26/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75659TA.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2005 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/18/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/15/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/05/2002 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |