Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 084644
Company: USL PHARMA

Products on ANDA 084644

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CHLORDIAZEPOXIDE HYDROCHLORIDE	CHLORDIAZEPOXIDE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 084644

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/1976	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
02/09/1994	SUPPL-60	Labeling		Label is not available on this site.
01/23/1989	SUPPL-59	Labeling		Label is not available on this site.
03/21/1988	SUPPL-57	Manufacturing (CMC)		Label is not available on this site.
05/29/1986	SUPPL-55	Manufacturing (CMC)		Label is not available on this site.
05/29/1986	SUPPL-54	Manufacturing (CMC)		Label is not available on this site.
03/05/1985	SUPPL-52	Manufacturing (CMC)		Label is not available on this site.
03/05/1985	SUPPL-51	Manufacturing (CMC)		Label is not available on this site.
01/20/1982	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
03/30/1982	SUPPL-44	Manufacturing (CMC)		Label is not available on this site.
03/30/1982	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
05/13/1982	SUPPL-41	Manufacturing (CMC)		Label is not available on this site.
05/25/1982	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/25/1982	SUPPL-23	Manufacturing (CMC)		Label is not available on this site.
05/25/1982	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.