Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 010571
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMPAZINE PROCHLORPERAZINE MALEATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
COMPAZINE PROCHLORPERAZINE MALEATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No
COMPAZINE PROCHLORPERAZINE MALEATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None No No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
10/23/1956 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
08/03/2005 SUPPL-96 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010571s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/010571s096ltr.pdf
04/03/2001 SUPPL-95 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
09/30/1992 SUPPL-86 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/21/1979 SUPPL-58 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/03/2005 SUPPL-96 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/010571s096lbl.pdf

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