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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 072277
Company: CHARTWELL RX
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
05/09/1988 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
01/17/2023 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert, Labeling-Medication Guide

Label is not available on this site.

02/05/2021 SUPPL-14 Labeling-Package Insert

Label is not available on this site.

12/16/2016 SUPPL-13 Labeling-Package Insert

Label is not available on this site.

04/25/2016 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

07/17/2014 SUPPL-11 Labeling-Package Insert

Label is not available on this site.

06/22/2009 SUPPL-9 Labeling

Label is not available on this site.

11/30/1995 SUPPL-8 Labeling

Label is not available on this site.

12/13/1993 SUPPL-7 Labeling

Label is not available on this site.

05/23/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

06/08/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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