Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012301
Company: BAUSCH
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
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.

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