Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 070765
Company: FRONTIDA BIOPHARM
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
12/10/1986 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
06/01/2017 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

04/25/2016 SUPPL-22 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/11/2014 SUPPL-21 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

11/07/1995 SUPPL-19 Labeling

Label is not available on this site.

12/23/1994 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

10/05/1993 SUPPL-17 Labeling

Label is not available on this site.

04/03/1992 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/11/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/11/1995 SUPPL-12 Labeling

Label is not available on this site.

01/11/1995 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

05/26/1989 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

03/08/1988 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/30/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

08/11/1987 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/24/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/16/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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