Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 084679
Company: UPSHER SMITH 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
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-85 Labeling-Package Insert

Label is not available on this site.

02/03/1995 SUPPL-81 Labeling

Label is not available on this site.

04/07/1989 SUPPL-79 Labeling

Label is not available on this site.

07/23/1987 SUPPL-77 Manufacturing (CMC)

Label is not available on this site.

07/23/1987 SUPPL-76 Manufacturing (CMC)

Label is not available on this site.

07/23/1987 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

01/08/1985 SUPPL-73 Manufacturing (CMC)

Label is not available on this site.

05/25/1984 SUPPL-71 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

01/13/1984 SUPPL-69 Manufacturing (CMC)

Label is not available on this site.

06/20/1983 SUPPL-68 Manufacturing (CMC)

Label is not available on this site.

07/22/1982 SUPPL-63 Manufacturing (CMC)

Label is not available on this site.

07/01/1982 SUPPL-62 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-60 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-59 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

03/15/1982 SUPPL-56 Manufacturing (CMC)

Label is not available on this site.

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