Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021019
Company: GLAXOSMITHKLINE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COMPAZINE PROCHLORPERAZINE MALEATE EQ 10MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
COMPAZINE PROCHLORPERAZINE MALEATE EQ 15MG BASE CAPSULE, EXTENDED RELEASE;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
10/06/1999 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019a.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/03/2001 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/06/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21019A_Compazine_appltrs_prntlbl.pdf

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