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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040105
Company: VINTAGE PHARMS
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
07/30/1996 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040105ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/04/2021 SUPPL-35 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

10/08/2019 SUPPL-34 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/21/2018 SUPPL-32 Labeling-Package Insert

Label is not available on this site.

09/18/2018 SUPPL-31 REMS - PROPOSAL - D-N-A

Label is not available on this site.

12/16/2016 SUPPL-28 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-27 Labeling-Container/Carton Labels

Label is not available on this site.

12/16/2016 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

10/18/2013 SUPPL-15 Labeling-Package Insert

Label is not available on this site.

07/21/2011 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

05/29/2007 SUPPL-5 Labeling

Label is not available on this site.

09/17/1997 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/17/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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