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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040122
Company: WATSON LABS
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
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 750MG;7.5MG 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
03/04/1996 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
03/27/2002 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

03/21/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

08/21/1998 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

07/08/1997 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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