Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 077712
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 15MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 30MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 5MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 10MG TABLET;ORAL Discontinued None No No
OXYCODONE HYDROCHLORIDE OXYCODONE HYDROCHLORIDE 20MG 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
01/31/2007 ORIG-1 Approval Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/anda/2007/077712Orig1s000Approv.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/18/2018 SUPPL-24 REMS - PROPOSAL - D-N-A

Label is not available on this site.

07/22/2009 SUPPL-5 Labeling

Label is not available on this site.

05/15/2009 SUPPL-4 Labeling

Label is not available on this site.

03/02/2009 SUPPL-2 Labeling

Label is not available on this site.

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