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FDA NDA · NDA017090

TOFRANIL-PM

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APPLICATION
NDA017090
TYPE
NDA
ORIGINAL APPROVAL
1973-03-11
LATEST ACTION
2014-07-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TOFRANIL-PM · ReferenceDiscontinued
IMIPRAMINE PAMOATE EQ 150MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TOFRANIL-PM · ReferenceDiscontinued
IMIPRAMINE PAMOATE EQ 125MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TOFRANIL-PM · ReferenceDiscontinued
IMIPRAMINE PAMOATE EQ 75MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
TOFRANIL-PM · ReferenceDiscontinued
IMIPRAMINE PAMOATE EQ 100MG HYDROCHLORIDE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2014-07-28Labeling · Supplement 78 · standard — Letter ↗AP
2014-07-10Labeling · Supplement 77 · 901 required — Label ↗AP
2012-10-26Labeling · Supplement 76 · standard — Letter ↗AP
2007-07-13Labeling · Supplement 74 · standard — Letter ↗AP
2005-01-12Labeling · Supplement 70 · standard — Letter ↗AP
2004-03-26Labeling · Supplement 69 · standard — Letter ↗AP
2002-06-20Manufacturing (CMC) · Supplement 68 · standardAP
2002-01-03Labeling · Supplement 67 · standardAP
2000-06-21Manufacturing (CMC) · Supplement 66 · standardAP
2000-04-26Manufacturing (CMC) · Supplement 65 · standardAP
2000-03-27Labeling · Supplement 62 · standardAP
2000-03-27Labeling · Supplement 60 · standardAP
2000-03-27Labeling · Supplement 61 · standardAP
1999-04-15Manufacturing (CMC) · Supplement 64 · standardAP
1997-07-31Manufacturing (CMC) · Supplement 63 · standardAP
1993-02-19Manufacturing (CMC) · Supplement 59 · standardAP
1992-12-08Labeling · Supplement 58AP
1991-08-02Manufacturing (CMC) · Supplement 57 · standardAP
1990-04-05Manufacturing (CMC) · Supplement 56 · standardAP
1989-10-25Manufacturing (CMC) · Supplement 54 · standardAP
1989-10-25Manufacturing (CMC) · Supplement 55 · standardAP
1989-08-08Manufacturing (CMC) · Supplement 53 · standardAP
1989-04-07Manufacturing (CMC) · Supplement 52 · standardAP
1987-08-12Efficacy · Supplement 51AP
1986-07-18Manufacturing (CMC) · Supplement 41 · standardAP
1986-05-20Manufacturing (CMC) · Supplement 50 · standardAP
1985-11-27Labeling · Supplement 49AP
1985-05-05Manufacturing (CMC) · Supplement 48 · standardAP
1985-04-26Labeling · Supplement 47AP
1984-11-05Manufacturing (CMC) · Supplement 44 · standardAP
1984-10-29Manufacturing (CMC) · Supplement 46 · standardAP
1984-03-26Labeling · Supplement 45AP
1983-05-04Manufacturing (CMC) · Supplement 42 · standardAP
1981-02-04Labeling · Supplement 40AP
1980-04-16Manufacturing (CMC) · Supplement 39 · standardAP
1980-04-16Manufacturing (CMC) · Supplement 38 · standardAP
1980-01-30Manufacturing (CMC) · Supplement 37 · standardAP
1979-12-28Manufacturing (CMC) · Supplement 33 · standardAP
1979-12-28Manufacturing (CMC) · Supplement 34 · standardAP
1979-06-07Manufacturing (CMC) · Supplement 35 · 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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