Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 009149
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SYRUP;ORAL Discontinued None Yes No
THORAZINE CHLORPROMAZINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CONCENTRATE;ORAL Discontinued None Yes No
THORAZINE CHLORPROMAZINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None Yes No
THORAZINE CHLORPROMAZINE HYDROCHLORIDE 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CONCENTRATE;ORAL Discontinued None Yes No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
11/20/1957 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
09/20/1996 SUPPL-178 Manufacturing (CMC)

Label is not available on this site.

02/14/1992 SUPPL-173 Manufacturing (CMC)

Label is not available on this site.

04/22/1998 SUPPL-165 Labeling

Label is not available on this site.

08/19/1994 SUPPL-151 Manufacturing (CMC)-Formulation

Label is not available on this site.

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