Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012301
Company: BAUSCH

Products on NDA 012301

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LIBRIUM	CHLORDIAZEPOXIDE HYDROCHLORIDE	100MG/AMP	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012301

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/21/1961	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/28/1998	SUPPL-24	Manufacturing (CMC)		Label is not available on this site.
05/07/2002	SUPPL-23	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12301s023ltr.pdf
02/03/1994	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
07/16/1992	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
08/06/1985	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
05/29/1985	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
03/29/1985	SUPPL-17	Labeling		Label is not available on this site.
02/03/1983	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
08/21/1980	SUPPL-14	Labeling		Label is not available on this site.
05/28/1980	SUPPL-13	Labeling		Label is not available on this site.
10/25/1979	SUPPL-12	Labeling		Label is not available on this site.
07/20/1979	SUPPL-11	Labeling		Label is not available on this site.
11/06/1978	SUPPL-10	Labeling		Label is not available on this site.
12/14/1977	SUPPL-8	Labeling		Label is not available on this site.