Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077677
Company: WOCKHARDT LTD
Company: WOCKHARDT LTD
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN | ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | 325MG;50MG | TABLET;ORAL | Discontinued | None | No | No |
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN | ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE | 650MG;100MG | 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 |
---|---|---|---|---|---|---|---|
03/16/2007 | 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 |
---|---|---|---|---|---|
12/30/2009 | SUPPL-1 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/077677s001ltr.pdf |