Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 040162
Company: IVAX SUB TEVA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 5MG BASE TABLET;ORAL Discontinued None No No
PROCHLORPERAZINE MALEATE PROCHLORPERAZINE MALEATE EQ 10MG BASE 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
01/20/1998 ORIG-1 Approval Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/29/2002 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

09/12/2001 SUPPL-9 Manufacturing (CMC)-Facility

Label is not available on this site.

11/13/2000 SUPPL-8 Manufacturing (CMC)-Facility

Label is not available on this site.

11/13/2000 SUPPL-7 Manufacturing (CMC)-Facility

Label is not available on this site.

10/17/2000 SUPPL-6 Labeling

Label is not available on this site.

05/01/2000 SUPPL-5 Manufacturing (CMC)-Facility

Label is not available on this site.

05/01/2000 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/2000 SUPPL-3 Manufacturing (CMC)-Facility

Label is not available on this site.

11/23/1999 SUPPL-2 Manufacturing (CMC)-Facility

Label is not available on this site.

12/09/1998 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/20/1998 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/anda/98/40162ap.pdf

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