Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 089696
Company: IVAX 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
04/21/1988 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
01/31/1997 SUPPL-6 Labeling

Label is not available on this site.

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

Label is not available on this site.

05/15/1991 SUPPL-2 Labeling

Label is not available on this site.

11/09/1990 SUPPL-1 Labeling

Label is not available on this site.

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