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Drugs@FDA: FDA-Approved Drugs

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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COMPAZINE PROCHLORPERAZINE MALEATE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
COMPAZINE PROCHLORPERAZINE MALEATE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
COMPAZINE PROCHLORPERAZINE MALEATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No

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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