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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017943
Company: MONARCH PHARMS

Products on NDA 017943

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 017943

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.

Labels for NDA 017943

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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