Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 086382
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORDIAZEPOXIDE HYDROCHLORIDE 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
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-33 Labeling-Package Insert

Label is not available on this site.

08/03/1998 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

08/03/1998 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

09/24/1997 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

09/24/1997 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

03/26/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

08/24/1988 SUPPL-26 Bioequivalence

Label is not available on this site.

06/22/1993 SUPPL-24 Labeling

Label is not available on this site.

10/11/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

10/11/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

10/11/1988 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

07/15/1988 SUPPL-20 Labeling

Label is not available on this site.

06/10/1988 SUPPL-19 Labeling

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

01/17/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

01/17/1986 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/03/1986 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

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