Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089907
Company: IVAX PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ALLAY ACETAMINOPHEN; HYDROCODONE BITARTRATE 500MG;5MG CAPSULE;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
01/13/1989 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-5 Labeling

Label is not available on this site.

05/05/1997 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/25/1991 SUPPL-1 Labeling

Label is not available on this site.

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