Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012249
Company: VALEANT PHARM INTL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG CAPSULE;ORAL Discontinued None No No
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 5MG CAPSULE;ORAL Discontinued None No No
LIBRIUM CHLORDIAZEPOXIDE HYDROCHLORIDE 25MG CAPSULE;ORAL 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
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.

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

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