Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040272
Company: DURAMED PHARMS BARR
Company: DURAMED PHARMS BARR
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | 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 |
---|---|---|---|---|---|---|---|
06/30/1998 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/40272ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40272ap.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/13/2002 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/13/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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06/29/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |