APPLICATION
ANDA084936
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 10MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 116 · standardAP
2023-05-24Labeling · Supplement 109 · standardAP
2016-02-02Labeling · Supplement 108 · standardAP
2014-07-17Labeling · Supplement 107 · standardAP
2008-03-10Labeling · Supplement 102AP
2007-06-25Labeling · Supplement 101AP
2007-02-09Labeling · Supplement 91AP
2005-06-15Labeling · Supplement 100AP
2002-04-19Manufacturing (CMC) · Supplement 97AP
2001-10-16Manufacturing (CMC) · Supplement 95AP
2001-05-09Manufacturing (CMC) · Supplement 96AP
2000-10-31Manufacturing (CMC) · Supplement 94AP
1999-05-11Labeling · Supplement 93AP
1999-05-05Manufacturing (CMC) · Supplement 92AP
1995-04-06Manufacturing (CMC) · Supplement 85AP
1995-03-21Labeling · Supplement 86AP
1994-03-11Labeling · Supplement 84AP
1989-11-07Labeling · Supplement 83AP
1988-02-22Manufacturing (CMC) · Supplement 82AP
1988-01-19Manufacturing (CMC) · Supplement 78AP
1988-01-19Manufacturing (CMC) · Supplement 80AP
1988-01-19Manufacturing (CMC) · Supplement 79AP
1988-01-19Manufacturing (CMC) · Supplement 77AP
1988-01-19Manufacturing (CMC) · Supplement 81AP
1986-01-16Manufacturing (CMC) · Supplement 73AP
1985-12-27Manufacturing (CMC) · Supplement 72AP
1983-10-21Manufacturing (CMC) · Supplement 66AP
1983-07-19Manufacturing (CMC) · Supplement 64AP
1982-12-10Manufacturing (CMC) · Supplement 62AP
1982-06-09Manufacturing (CMC) · Supplement 58AP
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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