Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084041
Company: UPSHER SMITH 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
06/15/1976 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-98 Labeling-Package Insert

Label is not available on this site.

02/03/1995 SUPPL-94 Labeling

Label is not available on this site.

11/03/1989 SUPPL-92 Labeling

Label is not available on this site.

05/01/1989 SUPPL-91 Labeling

Label is not available on this site.

01/08/1985 SUPPL-89 Manufacturing (CMC)

Label is not available on this site.

05/25/1984 SUPPL-86 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-85 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-84 Manufacturing (CMC)

Label is not available on this site.

06/21/1983 SUPPL-82 Manufacturing (CMC)

Label is not available on this site.

08/17/1982 SUPPL-79 Manufacturing (CMC)

Label is not available on this site.

08/17/1982 SUPPL-78 Manufacturing (CMC)

Label is not available on this site.

06/28/1982 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

05/27/1982 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

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