Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040341
Company: VINTAGE PHARMS LLC
Company: VINTAGE PHARMS LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
PERCOCET | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 650MG;10MG | 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 |
---|---|---|---|---|---|---|---|
07/26/1999 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/40341ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/99/40-341_Oxycodone%20And%20Acetaminophen.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
11/30/2006 | SUPPL-13 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf | |
07/31/2002 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/21/2001 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
10/18/2001 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
05/18/2000 | SUPPL-6 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
05/18/2000 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
01/11/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
11/02/1999 | SUPPL-3 | Labeling |
Label is not available on this site. |
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05/18/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
05/18/2000 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
11/30/2006 | SUPPL-13 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/040330s015,040341s013,040434s003lbl.pdf |