Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086294
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE HYDROCHLORIDE CHLORDIAZEPOXIDE HYDROCHLORIDE 10MG 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
09/08/1978 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-39 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

08/03/1998 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

08/03/1998 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

09/03/1997 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

09/03/1997 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

09/03/1997 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

03/25/1997 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/22/1993 SUPPL-30 Labeling

Label is not available on this site.

08/31/1989 SUPPL-29 Bioequivalence

Label is not available on this site.

01/28/1994 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

10/11/1988 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

10/11/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

07/15/1988 SUPPL-23 Labeling

Label is not available on this site.

06/10/1988 SUPPL-22 Labeling

Label is not available on this site.

01/26/1989 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/17/1987 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

12/27/1985 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

02/09/1984 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

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