Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040240
Company: MUTUAL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;10MG TABLET;ORAL Discontinued None No No
HYDROCODONE BITARTRATE AND ACETAMINOPHEN ACETAMINOPHEN; HYDROCODONE BITARTRATE 650MG;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
11/26/1997 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
07/24/2002 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.

02/08/2002 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

09/24/2001 SUPPL-6 Manufacturing (CMC)-Facility

Label is not available on this site.

11/02/2001 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-4 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

12/18/2000 SUPPL-1 Manufacturing (CMC)-Facility

Label is not available on this site.

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