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FDA NDA · NDA017376

SEPTRA

Sponsor: MONARCH PHARMS

APPLICATION
NDA017376
TYPE
NDA
ORIGINAL APPROVAL
1973-07-30
LATEST ACTION
2025-02-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SEPTRADiscontinued
SULFAMETHOXAZOLE 400MG, TRIMETHOPRIM 80MG · TABLET · ORAL
SEPTRA DSDiscontinued
SULFAMETHOXAZOLE 800MG, TRIMETHOPRIM 160MG · TABLET · ORAL

Approval history

2025-02-21Labeling · Supplement 68 · standard — Label ↗AP
2024-06-24Labeling · Supplement 66 · standard — Letter ↗AP
2020-11-18Labeling · Supplement 62 · standard — Label ↗AP
2020-08-10Labeling · Supplement 63 · standard — Letter ↗AP
2020-08-10Labeling · Supplement 64 · standard — Letter ↗AP
2020-07-15Labeling · Supplement 65 · standard — Label ↗AP
2018-02-01Labeling · Supplement 61 · standard — Label ↗AP
2013-08-30Labeling · Supplement 60 · standard — Letter ↗AP
2008-03-11Labeling · Supplement 58 · standard — Letter ↗AP
2007-09-10Labeling · Supplement 59 · standard — Letter ↗AP
2005-07-28Labeling · Supplement 56 · standard — Letter ↗AP
2000-10-04Manufacturing (CMC) · Supplement 55 · priorityAP
2000-01-31Manufacturing (CMC) · Supplement 54 · priorityAP
1998-04-07Labeling · Supplement 52 · standardAP
1997-03-19Labeling · Supplement 51 · standardAP
1997-03-19Labeling · Supplement 44AP
1997-03-19Labeling · Supplement 42AP
1997-02-12Labeling · Supplement 53 · standardAP
1996-09-11Labeling · Supplement 48 · standardAP
1994-01-07Labeling · Supplement 47 · standardAP
1993-02-22Manufacturing (CMC) · Supplement 46 · priorityAP
1992-12-01Manufacturing (CMC) · Supplement 45 · priorityAP
1990-11-09Labeling · Supplement 39AP
1990-06-15Efficacy · Supplement 41AP
1989-02-02Labeling · Supplement 40AP
1987-08-11Labeling · Supplement 37AP
1985-08-09Manufacturing (CMC) · Supplement 38 · priorityAP
1985-02-20Manufacturing (CMC) · Supplement 35 · priorityAP
1985-01-16Manufacturing (CMC) · Supplement 36 · priorityAP
1984-11-01Labeling · Supplement 31AP
1983-03-25Manufacturing (CMC) · Supplement 33 · priorityAP
1982-12-07Manufacturing (CMC) · Supplement 32 · priorityAP
1982-04-27Labeling · Supplement 30AP
1981-11-03Manufacturing (CMC) · Supplement 29 · priorityAP
1981-10-09Manufacturing (CMC) · Supplement 28 · priorityAP
1981-01-09Manufacturing (CMC) · Supplement 27 · priorityAP
1980-10-31Labeling · Supplement 26AP
1980-10-28Manufacturing (CMC) · Supplement 24 · priorityAP
1980-09-09Manufacturing (CMC) · Supplement 25 · priorityAP
1979-07-26Efficacy · Supplement 21AP
VIEW ON DRUGS@FDA ↗

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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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