APPLICATION
ANDA089399
TYPE
ANDA
ORIGINAL APPROVAL
1987-07-14
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 100MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEPrescription
AMITRIPTYLINE HYDROCHLORIDE 150MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 52 · standardAP
2019-03-19Manufacturing (CMC) · Supplement 45 · unknownAP
2016-04-25Labeling · Supplement 43 · standardAP
2014-07-17Labeling · Supplement 39 · standardAP
2007-11-21Labeling · Supplement 34AP
2007-06-29Labeling · Supplement 33AP
2007-04-12Labeling · Supplement 32AP
2007-04-12Manufacturing (CMC) · Supplement 30AP
2005-08-26Labeling · Supplement 26AP
2005-05-05Labeling · Supplement 25AP
2002-09-30Manufacturing (CMC) · Supplement 17AP
2001-08-07Labeling · Supplement 13AP
2001-08-07Manufacturing (CMC) · Supplement 14AP
2001-08-07Manufacturing (CMC) · Supplement 15AP
2001-07-05Manufacturing (CMC) · Supplement 12AP
2001-03-22Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
1997-12-05Manufacturing (CMC) · Supplement 8AP
1997-02-24Manufacturing (CMC) · Supplement 7AP
1995-08-22Labeling · Supplement 6AP
1995-06-22Manufacturing (CMC) · Supplement 5AP
1994-01-12Manufacturing (CMC) · Supplement 4AP
1993-08-16Labeling · Supplement 3AP
1992-05-15Labeling · Supplement 2AP
1992-02-27Manufacturing (CMC) · Supplement 1AP
1987-07-14OriginalAP
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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