APPLICATION
ANDA040218
TYPE
ANDA
ORIGINAL APPROVAL
1997-09-11
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 100MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 150MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 38 · standardAP
2016-04-25Labeling · Supplement 23 · standardAP
2014-07-17Labeling · Supplement 19 · standardAP
2010-04-26Labeling · Supplement 15AP
2007-11-21Labeling · Supplement 14AP
2007-06-29Labeling · Supplement 12AP
2005-10-06Labeling · Supplement 9AP
2005-08-03Labeling · Supplement 8AP
2002-03-26Manufacturing (CMC) · Supplement 3AP
1997-09-11OriginalAP
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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