← FDA DRUG APPROVALS

FDA NDA · NDA014399

NORPRAMIN

desipramine hydrochloride

Sponsor: VALIDUS PHARMS

APPLICATION
NDA014399
TYPE
NDA
ORIGINAL APPROVAL
1964-11-20
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NORPRAMIN · ReferenceDiscontinued
DESIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
NORPRAMIN · ReferenceDiscontinued
DESIPRAMINE HYDROCHLORIDE 100MG · TABLET · ORAL
NORPRAMIN · ReferenceDiscontinued
DESIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL
NORPRAMIN · ReferenceDiscontinued
DESIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
NORPRAMIN · ReferenceDiscontinued
DESIPRAMINE HYDROCHLORIDE 150MG · TABLET · ORAL
NORPRAMIN · ReferenceDiscontinued
DESIPRAMINE HYDROCHLORIDE 75MG · TABLET · ORAL

Approval history

2025-06-24Labeling · Supplement 72 · 901 required — Letter ↗AP
2018-11-09Labeling · Supplement 71 · standard — Label ↗AP
2014-08-07Manufacturing (CMC) · Supplement 68 · standardAP
2014-07-02Labeling · Supplement 69 · 901 required — Letter ↗AP
2012-11-19Labeling · Supplement 66 · unknown — Letter ↗AP
2012-11-19Labeling · Supplement 67 · standard — Letter ↗AP
2009-10-26Labeling · Supplement 65 · unknown — Label ↗AP
2007-07-30Labeling · Supplement 64 · standard — Letter ↗AP
2006-04-11Labeling · Supplement 63 · standard — Label ↗AP
2005-01-12Labeling · Supplement 62 · standard — Letter ↗AP
2000-05-23Labeling · Supplement 58 · standardAP
2000-05-23Labeling · Supplement 60 · standardAP
2000-05-23Labeling · Supplement 55AP
2000-05-23Labeling · Supplement 61 · standardAP
1992-09-03Manufacturing (CMC) · Supplement 56 · standardAP
1991-12-11Labeling · Supplement 52AP
1991-12-11Labeling · Supplement 53AP
1990-12-10Labeling · Supplement 42AP
1990-12-10Labeling · Supplement 49AP
1990-04-25Manufacturing (CMC) · Supplement 50 · standardAP
1989-06-19Manufacturing (CMC) · Supplement 51 · standardAP
1989-03-21Manufacturing (CMC) · Supplement 48 · standardAP
1988-11-15Manufacturing (CMC) · Supplement 45 · standardAP
1988-06-20Manufacturing (CMC) · Supplement 46 · standardAP
1988-03-30Manufacturing (CMC) · Supplement 47 · standardAP
1987-04-03Manufacturing (CMC) · Supplement 44 · standardAP
1986-06-24Manufacturing (CMC) · Supplement 43 · standardAP
1985-04-29Labeling · Supplement 40AP
1982-06-22Manufacturing (CMC) · Supplement 38 · standardAP
1982-06-22Manufacturing (CMC) · Supplement 37 · standardAP
1982-02-11Manufacturing (CMC) · Supplement 33 · standardAP
1982-02-01Manufacturing (CMC) · Supplement 35 · standardAP
1982-02-01Manufacturing (CMC) · Supplement 36 · standardAP
1982-02-01Manufacturing (CMC) · Supplement 34 · standardAP
1982-02-01Manufacturing (CMC) · Supplement 32 · standardAP
1980-08-18Labeling · Supplement 30AP
1980-07-28Labeling · Supplement 31AP
1980-02-14Manufacturing (CMC) · Supplement 29 · standardAP
1977-03-01Labeling · Supplement 27AP
1976-06-25Efficacy · Supplement 20AP
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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