APPLICATION
ANDA084937
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 50MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 136 · standardAP
2023-05-24Labeling · Supplement 129 · standardAP
2016-02-02Labeling · Supplement 128 · standardAP
2014-07-17Labeling · Supplement 127 · standardAP
2008-03-10Labeling · Supplement 120AP
2007-06-25Labeling · Supplement 119AP
2007-02-09Labeling · Supplement 106AP
2005-06-15Labeling · Supplement 118AP
2002-04-19Manufacturing (CMC) · Supplement 115AP
2001-10-16Manufacturing (CMC) · Supplement 113AP
2001-05-09Manufacturing (CMC) · Supplement 114AP
2000-10-31Manufacturing (CMC) · Supplement 112AP
1999-06-01Labeling · Supplement 108AP
1999-05-11Labeling · Supplement 111AP
1999-05-05Manufacturing (CMC) · Supplement 110AP
1999-05-01Manufacturing (CMC) · Supplement 107AP
1995-04-06Manufacturing (CMC) · Supplement 101AP
1995-03-21Labeling · Supplement 102AP
1994-03-11Labeling · Supplement 100AP
1991-04-15Labeling · Supplement 99AP
1990-10-02Manufacturing (CMC) · Supplement 96AP
1989-11-07Labeling · Supplement 98AP
1989-09-15Labeling · Supplement 97AP
1988-02-22Labeling · Supplement 93AP
1988-02-22Manufacturing (CMC) · Supplement 91AP
1988-02-22Manufacturing (CMC) · Supplement 94AP
1988-02-22Manufacturing (CMC) · Supplement 92AP
1988-02-22Manufacturing (CMC) · Supplement 90AP
1988-02-22Manufacturing (CMC) · Supplement 89AP
1987-04-09Manufacturing (CMC) · Supplement 87AP
1986-07-30Manufacturing (CMC) · Supplement 85AP
1986-07-30Manufacturing (CMC) · Supplement 81AP
1986-07-30Manufacturing (CMC) · Supplement 82AP
1986-07-30Manufacturing (CMC) · Supplement 80AP
1986-01-16Manufacturing (CMC) · Supplement 79AP
1985-12-27Manufacturing (CMC) · Supplement 78AP
1983-10-21Manufacturing (CMC) · Supplement 73AP
1983-07-21Manufacturing (CMC) · Supplement 71AP
1982-12-10Manufacturing (CMC) · Supplement 69AP
1982-12-10Manufacturing (CMC) · Supplement 68AP
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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