Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 072052
Company: HERITAGE PHARMA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE EQ 12.5MG BASE;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
12/16/1988 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
12/16/2016 SUPPL-10 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

04/25/2016 SUPPL-9 Labeling-Package Insert

Label is not available on this site.

12/22/2014 SUPPL-8 Labeling-Package Insert

Label is not available on this site.

12/08/1995 SUPPL-6 Labeling

Label is not available on this site.

11/24/1993 SUPPL-5 Labeling

Label is not available on this site.

01/28/1991 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

05/31/1991 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/25/1989 SUPPL-1 Labeling

Label is not available on this site.

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