Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089971
Company: VINTAGE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;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
12/02/1988 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
11/18/2002 SUPPL-14 Labeling

Label is not available on this site.

05/30/1997 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

05/30/1997 SUPPL-4 Labeling

Label is not available on this site.

09/13/1996 SUPPL-3 Labeling

Label is not available on this site.

06/25/1992 SUPPL-2 Labeling

Label is not available on this site.

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