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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011552
Company: GLAXOSMITHKLINE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
STELAZINE TRIFLUOPERAZINE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
STELAZINE TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
STELAZINE TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
STELAZINE TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
STELAZINE TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE;INJECTION Discontinued None Yes No
STELAZINE TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CONCENTRATE;ORAL Discontinued None Yes No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
04/16/1959 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD

Label is not available on this site.
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/18/2001 SUPPL-113 Manufacturing (CMC)

Label is not available on this site.
04/03/2001 SUPPL-112 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/11552S112ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/11-552SLR112.pdf
10/14/1997 SUPPL-111 Manufacturing (CMC)-Control

Label is not available on this site.
08/14/1996 SUPPL-110 Manufacturing (CMC)-Packaging

Label is not available on this site.
05/03/1979 SUPPL-71 Labeling

Label is not available on this site.
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