Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 084678
Company: CHARTWELL RX

Products on ANDA 084678

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084678

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/15/1976	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-91	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-88	Labeling-Package Insert		Label is not available on this site.
02/03/1995	SUPPL-84	Labeling		Label is not available on this site.
11/21/1989	SUPPL-82	Labeling		Label is not available on this site.
04/07/1989	SUPPL-81	Labeling		Label is not available on this site.
01/08/1985	SUPPL-79	Manufacturing (CMC)		Label is not available on this site.
05/25/1984	SUPPL-77	Manufacturing (CMC)		Label is not available on this site.
01/13/1984	SUPPL-76	Manufacturing (CMC)		Label is not available on this site.
01/13/1984	SUPPL-75	Manufacturing (CMC)		Label is not available on this site.
06/20/1983	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
07/26/1982	SUPPL-70	Manufacturing (CMC)		Label is not available on this site.
07/26/1982	SUPPL-69	Manufacturing (CMC)		Label is not available on this site.
07/01/1982	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-66	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-65	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-64	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-62	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-61	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084678

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	084768	BARR
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	084678	CHARTWELL RX
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	Yes	AB	085461	VALEANT PHARM INTL