APPLICATION
ANDA083745
TYPE
ANDA
ORIGINAL APPROVAL
1976-04-20
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
IMIPRAMINE HYDROCHLORIDEPrescription
IMIPRAMINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 130 · standardAP
2023-05-24Labeling · Supplement 123 · standardAP
2016-02-02Labeling · Supplement 122 · standardAP
2014-07-17Labeling · Supplement 121 · standardAP
2008-03-10Labeling · Supplement 114AP
2007-06-25Labeling · Supplement 113AP
2007-02-09Labeling · Supplement 100AP
2005-06-15Labeling · Supplement 112AP
2002-04-19Manufacturing (CMC) · Supplement 109AP
2001-10-16Manufacturing (CMC) · Supplement 107AP
2001-05-09Manufacturing (CMC) · Supplement 108AP
2000-10-31Manufacturing (CMC) · Supplement 106AP
1999-06-01Manufacturing (CMC) · Supplement 101AP
1999-06-01Labeling · Supplement 102AP
1999-05-11Labeling · Supplement 105AP
1999-05-05Manufacturing (CMC) · Supplement 104AP
1995-04-06Manufacturing (CMC) · Supplement 95AP
1995-03-21Labeling · Supplement 96AP
1994-03-11Labeling · Supplement 94AP
1991-06-13Manufacturing (CMC) · Supplement 92AP
1991-06-13Manufacturing (CMC) · Supplement 91AP
1989-05-15Bioequivalence · Supplement 93AP
1988-02-22Manufacturing (CMC) · Supplement 86AP
1988-02-22Manufacturing (CMC) · Supplement 90AP
1988-02-22Manufacturing (CMC) · Supplement 89AP
1988-02-22Manufacturing (CMC) · Supplement 87AP
1988-02-22Manufacturing (CMC) · Supplement 85AP
1986-05-29Manufacturing (CMC) · Supplement 82AP
1986-03-11Manufacturing (CMC) · Supplement 78AP
1986-03-11Manufacturing (CMC) · Supplement 79AP
1986-03-11Manufacturing (CMC) · Supplement 77AP
1985-12-27Manufacturing (CMC) · Supplement 80AP
1983-10-21Manufacturing (CMC) · Supplement 72AP
1983-07-25Manufacturing (CMC) · Supplement 70AP
1982-12-10Manufacturing (CMC) · Supplement 67AP
1982-04-07Manufacturing (CMC) · Supplement 65AP
1976-04-20OriginalAP
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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