Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012249
Company: VALEANT PHARM INTL

• Medication Guide

Products on NDA 012249

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012249

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/24/1960	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2016	SUPPL-49	Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/012249Orig1s049ltr.pdf
06/02/1983	SUPPL-47	Manufacturing (CMC)		Label is not available on this site.
01/26/1982	SUPPL-45	Manufacturing (CMC)-Control		Label is not available on this site.
01/26/1982	SUPPL-44	Manufacturing (CMC)-Control		Label is not available on this site.
06/03/1980	SUPPL-43	Labeling		Label is not available on this site.
10/25/1979	SUPPL-42	Labeling		Label is not available on this site.
07/24/1978	SUPPL-41	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
03/31/1978	SUPPL-40	Labeling		Label is not available on this site.
02/18/1977	SUPPL-39	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/18/1977	SUPPL-38	Manufacturing (CMC)-Formulation		Label is not available on this site.
12/14/1976	SUPPL-36	Labeling		Label is not available on this site.
10/18/1976	SUPPL-35	Labeling		Label is not available on this site.
04/29/1974	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.

Labels for NDA 012249

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/16/2016	SUPPL-49	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/012249s049lbl.pdf