Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 085475
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription AB No Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/21/1977 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
12/16/2016 SUPPL-50 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/26/2002 SUPPL-46 Labeling

Label is not available on this site.

09/26/2002 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

09/26/2002 SUPPL-44 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/26/2002 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

09/26/2002 SUPPL-42 Manufacturing (CMC)-Facility

Label is not available on this site.

10/20/1997 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

11/28/1997 SUPPL-40 Manufacturing (CMC)

Label is not available on this site.

11/03/1994 SUPPL-39 Labeling

Label is not available on this site.

03/27/1991 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/06/1989 SUPPL-37 Labeling

Label is not available on this site.

02/22/1989 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/01/1988 SUPPL-35 Labeling

Label is not available on this site.

11/02/1987 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

06/07/1984 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/09/1983 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

07/14/1982 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

05/14/1982 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/30/1982 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

LIBRIUM

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
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG CAPSULE;ORAL Prescription No AB 085475 VALEANT PHARM INTL

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