← FDA DRUG APPROVALS

FDA NDA · NDA019906

CLOMIPRAMINE HYDROCHLORIDE

Sponsor: SPECGX LLC

APPLICATION
NDA019906
TYPE
NDA
ORIGINAL APPROVAL
1989-12-29
LATEST ACTION
2019-05-10
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ANAFRANIL · ReferencePrescription
CLOMIPRAMINE HYDROCHLORIDE 75MG · CAPSULE · ORAL
ANAFRANIL · ReferencePrescription
CLOMIPRAMINE HYDROCHLORIDE 25MG · CAPSULE · ORAL
ANAFRANIL · ReferencePrescription
CLOMIPRAMINE HYDROCHLORIDE 50MG · CAPSULE · ORAL

Approval history

2019-05-10Labeling · Supplement 43 · 901 required — Label ↗AP
2018-08-22Labeling · Supplement 41 · standard — Letter ↗AP
2017-05-24Labeling · Supplement 40 · standard — Letter ↗AP
2014-07-28Labeling · Supplement 39 · standard — Label ↗AP
2014-07-10Labeling · Supplement 38 · 901 required — Label ↗AP
2012-10-26Labeling · Supplement 37 · standard — Label ↗AP
2007-07-13Labeling · Supplement 34 · standard — Label ↗AP
2005-01-12Labeling · Supplement 32 · standard — Label ↗AP
2004-09-03Labeling · Supplement 30 · standard — Letter ↗AP
2002-06-20Manufacturing (CMC) · Supplement 28 · priorityAP
2001-07-31Labeling · Supplement 9 — Label ↗AP
2001-03-23Manufacturing (CMC) · Supplement 27 · priorityAP
2000-10-31Manufacturing (CMC) · Supplement 26 · priorityAP
2000-07-03Manufacturing (CMC) · Supplement 25 · priorityAP
1999-04-15Manufacturing (CMC) · Supplement 24 · priorityAP
1999-03-08Manufacturing (CMC) · Supplement 23 · priorityAP
1999-01-04Labeling · Supplement 22 · standard — Review ↗AP
1998-05-18Manufacturing (CMC) · Supplement 21 · priorityAP
1998-01-15Labeling · Supplement 20 · standardAP
1997-04-02Labeling · Supplement 19 · standardAP
1997-04-02Labeling · Supplement 17 · standardAP
1997-02-11Manufacturing (CMC) · Supplement 18 · priorityAP
1995-12-14Manufacturing (CMC) · Supplement 15 · priorityAP
1995-11-22Manufacturing (CMC) · Supplement 16 · priorityAP
1995-10-20Manufacturing (CMC) · Supplement 14 · priorityAP
1995-10-05Manufacturing (CMC) · Supplement 13 · priorityAP
1994-07-13Manufacturing (CMC) · Supplement 11 · priorityAP
1994-07-01Manufacturing (CMC) · Supplement 10 · priorityAP
1994-04-13Labeling · Supplement 8AP
1994-04-13Labeling · Supplement 12AP
1991-05-15Manufacturing (CMC) · Supplement 6 · priorityAP
1991-04-09Labeling · Supplement 7AP
1991-04-09Labeling · Supplement 5AP
1991-04-09Labeling · Supplement 1AP
1991-01-31Manufacturing (CMC) · Supplement 4 · priorityAP
1989-12-29Type 1 - New Molecular Entity · Original · priority — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →