Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075128
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AFEDITAB CR | NIFEDIPINE | 30MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/10/2000 | ORIG-1 | Approval |
Letter (PDF)
Letter (PDF) Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75128ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75128ta.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/075128.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/03/2005 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 12/30/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/2002 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 01/17/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/23/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |