Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011000
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
COMPAZINE PROCHLORPERAZINE MALEATE EQ 30MG BASE CAPSULE, EXTENDED RELEASE;ORAL Discontinued None No No
COMPAZINE PROCHLORPERAZINE MALEATE EQ 75MG 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
06/05/1957 ORIG-1 Approval Type 3 - New Dosage Form 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-84 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/10571S95ltr.pdf
08/21/1979 SUPPL-46 Labeling

Label is not available on this site.

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