Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084679
Company: CHARTWELL RX

Products on ANDA 084679

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084679

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-88	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
12/16/2016	SUPPL-85	Labeling-Package Insert		Label is not available on this site.
02/03/1995	SUPPL-81	Labeling		Label is not available on this site.
04/07/1989	SUPPL-79	Labeling		Label is not available on this site.
07/23/1987	SUPPL-77	Manufacturing (CMC)		Label is not available on this site.
07/23/1987	SUPPL-76	Manufacturing (CMC)		Label is not available on this site.
07/23/1987	SUPPL-75	Manufacturing (CMC)		Label is not available on this site.
01/08/1985	SUPPL-73	Manufacturing (CMC)		Label is not available on this site.
05/25/1984	SUPPL-71	Manufacturing (CMC)		Label is not available on this site.
01/13/1984	SUPPL-70	Manufacturing (CMC)		Label is not available on this site.
01/13/1984	SUPPL-69	Manufacturing (CMC)		Label is not available on this site.
06/20/1983	SUPPL-68	Manufacturing (CMC)		Label is not available on this site.
07/22/1982	SUPPL-63	Manufacturing (CMC)		Label is not available on this site.
07/01/1982	SUPPL-62	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-60	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-59	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-58	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
03/15/1982	SUPPL-56	Manufacturing (CMC)		Label is not available on this site.

Therapeutic Equivalents for ANDA 084679

CHLORDIAZEPOXIDE HYDROCHLORIDE

CAPSULE;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	084769	BARR
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	No	AB	084679	CHARTWELL RX
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG	CAPSULE;ORAL	Prescription	Yes	AB	085475	BAUSCH