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FDA ANDA · ANDA087846

IMIPRAMINE HYDROCHLORIDE

Sponsor: SPECGX LLC

APPLICATION
ANDA087846
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-22
LATEST ACTION
2017-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

IMIPRAMINE HYDROCHLORIDE · ReferenceDiscontinued
IMIPRAMINE HYDROCHLORIDE 10MG · TABLET · ORAL
IMIPRAMINE HYDROCHLORIDE · ReferenceDiscontinued
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
TOFRANIL · ReferenceDiscontinued
IMIPRAMINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2017-06-29Labeling · Supplement 29 · standardAP
2014-07-17Labeling · Supplement 28 · standard — Medication Guide ↗AP
2007-09-27Labeling · Supplement 26 — Letter ↗AP
2007-06-25Labeling · Supplement 25AP
2005-09-12Labeling · Supplement 23AP
2005-06-09Labeling · Supplement 22AP
2004-08-31Labeling · Supplement 21AP
2002-06-12Manufacturing (CMC) · Supplement 20AP
2000-09-14Manufacturing (CMC) · Supplement 19AP
2000-09-14Manufacturing (CMC) · Supplement 18AP
1999-07-15Manufacturing (CMC) · Supplement 17AP
1998-09-01Labeling · Supplement 15AP
1997-09-26Manufacturing (CMC) · Supplement 16AP
1994-12-20Labeling · Supplement 13AP
1993-02-25Manufacturing (CMC) · Supplement 12AP
1993-02-02Labeling · Supplement 10AP
1992-12-14Manufacturing (CMC) · Supplement 8AP
1992-12-14Manufacturing (CMC) · Supplement 11AP
1986-10-23Manufacturing (CMC) · Supplement 7AP
1986-07-25Manufacturing (CMC) · Supplement 6AP
1986-07-25Manufacturing (CMC) · Supplement 5AP
1984-05-22Original — 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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