← FDA DRUG APPROVALS

FDA NDA · NDA017943

PROLOPRIM

Sponsor: MONARCH PHARMS

APPLICATION
NDA017943
TYPE
NDA
ORIGINAL APPROVAL
1980-05-30
LATEST ACTION
2009-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PROLOPRIMDiscontinued
TRIMETHOPRIM 200MG · TABLET · ORAL
PROLOPRIMDiscontinued
TRIMETHOPRIM 100MG · TABLET · ORAL

Approval history

2009-03-13Labeling · Supplement 9AP
2006-01-13Labeling · Supplement 17 · standard — Letter ↗AP
2002-08-26Labeling · Supplement 16 · standard — Letter ↗AP
1999-08-06Labeling · Supplement 10AP
1999-08-06Labeling · Supplement 15 · standardAP
1997-01-08Labeling · Supplement 14 · standardAP
1996-02-14Labeling · Supplement 12 · standardAP
1992-12-01Manufacturing (CMC) · Supplement 11 · standardAP
1986-12-18Labeling · Supplement 5AP
1986-12-02Labeling · Supplement 8AP
1986-09-29Manufacturing (CMC) · Supplement 7 · standardAP
1983-03-25Manufacturing (CMC) · Supplement 6 · standardAP
1982-08-16Labeling · Supplement 4AP
1982-07-14Manufacturing (CMC) · Supplement 1 · standardAP
1982-04-19Manufacturing (CMC) · Supplement 3 · standardAP
1981-11-03Manufacturing (CMC) · Supplement 2 · standardAP
1980-05-30Type 3 - New Dosage Form · Original · standardAP
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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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