Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075152
Company: WATSON LABS TEVA
Company: WATSON LABS TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DICLOFENAC POTASSIUM | DICLOFENAC POTASSIUM | 50MG | TABLET;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 |
---|---|---|---|---|---|---|---|
11/27/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75152ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/07/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
08/31/2001 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/10/1999 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |