Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 017943
Company: MONARCH PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PROLOPRIM TRIMETHOPRIM 100MG TABLET;ORAL Discontinued None No No
PROLOPRIM TRIMETHOPRIM 200MG 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
05/30/1980 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
01/13/2006 SUPPL-17 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/017943s017ltr.pdf
08/26/2002 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17943s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17943slr016ltr.pdf
08/06/1999 SUPPL-15 Labeling

Label is not available on this site.

01/08/1997 SUPPL-14 Labeling

Label is not available on this site.

02/14/1996 SUPPL-12 Labeling

Label is not available on this site.

12/01/1992 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.

08/06/1999 SUPPL-10 Labeling

Label is not available on this site.

03/13/2009 SUPPL-9 Labeling

Label is not available on this site.

12/02/1986 SUPPL-8 Labeling

Label is not available on this site.

09/29/1986 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/25/1983 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/18/1986 SUPPL-5 Labeling

Label is not available on this site.

08/16/1982 SUPPL-4 Labeling

Label is not available on this site.

04/19/1982 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/03/1981 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

07/14/1982 SUPPL-1 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/26/2002 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/17943s16lbl.pdf

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