Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 070765
Company: ANDA REPOSITORY

• Safety Labeling Change Order Letter

Products on ANDA 070765

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 070765

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
02/05/2021	SUPPL-25	Labeling-Package Insert		Label is not available on this site.
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.