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FDA NDA · NDA016792

SURMONTIL

Sponsor: TEVA WOMENS

APPLICATION
NDA016792
TYPE
NDA
ORIGINAL APPROVAL
1979-06-12
LATEST ACTION
2014-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

SURMONTIL · ReferenceDiscontinued
TRIMIPRAMINE MALEATE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SURMONTIL · ReferenceDiscontinued
TRIMIPRAMINE MALEATE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
SURMONTIL · ReferenceDiscontinued
TRIMIPRAMINE MALEATE EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2014-09-30Manufacturing (CMC) · Supplement 36 · standardAP
2014-07-17Labeling · Supplement 37 · 901 required — Medication Guide ↗AP
2013-12-23Manufacturing (CMC) · Supplement 35 · standardAP
2012-12-03Labeling · Supplement 34 · standard — Label ↗AP
2007-08-01Labeling · Supplement 25 · standard — Label ↗AP
2005-01-12Labeling · Supplement 24 · standard — Letter ↗AP
2000-05-01Labeling · Supplement 20 · standard — Review ↗AP
2000-04-27Labeling · Supplement 18 · standard — Review ↗AP
2000-04-27Labeling · Supplement 19 · standard — Review ↗AP
2000-04-27Labeling · Supplement 15 — Review ↗AP
1992-04-03Manufacturing (CMC) · Supplement 16 · standardAP
1992-04-03Manufacturing (CMC) · Supplement 17 · standardAP
1991-12-16Manufacturing (CMC) · Supplement 14 · standardAP
1988-06-17Manufacturing (CMC) · Supplement 11 · standardAP
1988-04-20Manufacturing (CMC) · Supplement 12 · standardAP
1987-07-24Manufacturing (CMC) · Supplement 10 · standardAP
1987-02-02Manufacturing (CMC) · Supplement 9 · standardAP
1982-11-12Manufacturing (CMC) · Supplement 6 · standardAP
1982-10-05Manufacturing (CMC) · Supplement 5 · standardAP
1982-09-15Manufacturing (CMC) · Supplement 3 · standardAP
1981-08-24Manufacturing (CMC) · Supplement 4 · standardAP
1981-03-26Manufacturing (CMC) · Supplement 2 · standardAP
1980-07-08Labeling · Supplement 1AP
1979-06-12Type 1 - New Molecular Entity · Original · standard — Other Important Information from FDA ↗AP
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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