Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011127
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMPAZINE PROCHLORPERAZINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None No No
COMPAZINE PROCHLORPERAZINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None No No
COMPAZINE PROCHLORPERAZINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUPPOSITORY;RECTAL Discontinued None No No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
01/26/1959 ORIG-1 Approval Type 2 - New Active Ingredient 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
04/03/2001 SUPPL-61 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
05/09/1997 SUPPL-60 Manufacturing (CMC)-Control

Label is not available on this site.

08/11/1994 SUPPL-59 Manufacturing (CMC)-Control

Label is not available on this site.

02/14/1992 SUPPL-57 Manufacturing (CMC)

Label is not available on this site.

08/21/1979 SUPPL-28 Labeling

Label is not available on this site.

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