APPLICATION
ANDA085031
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-16
LATEST ACTION
2025-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
2025-06-24Labeling · Supplement 289 · standardAP
2025-06-16Labeling · Supplement 288 · standardAP
2016-04-25Labeling · Supplement 287 · standardAP
2014-11-17Labeling · Supplement 286 · standardAP
1997-06-18Manufacturing (CMC) · Supplement 285AP
1995-06-11Labeling · Supplement 284AP
1995-02-16Manufacturing (CMC) · Supplement 282AP
1995-02-15Manufacturing (CMC) · Supplement 283AP
1994-11-30Manufacturing (CMC) · Supplement 281AP
1994-09-06Manufacturing (CMC) · Supplement 280AP
1994-06-17Manufacturing (CMC) · Supplement 279AP
1994-03-23Manufacturing (CMC) · Supplement 278AP
1993-08-18Labeling · Supplement 277AP
1992-06-12Labeling · Supplement 276AP
1992-06-10Manufacturing (CMC) · Supplement 272AP
1991-12-31Labeling · Supplement 273AP
1989-04-05Manufacturing (CMC) · Supplement 271AP
1988-03-31Manufacturing (CMC) · Supplement 268AP
1988-03-31Manufacturing (CMC) · Supplement 269AP
1987-11-04Manufacturing (CMC) · Supplement 265AP
1987-09-30Manufacturing (CMC) · Supplement 266AP
1987-09-30Manufacturing (CMC) · Supplement 263AP
1986-04-28Manufacturing (CMC) · Supplement 262AP
1986-04-28Manufacturing (CMC) · Supplement 261AP
1986-03-12Manufacturing (CMC) · Supplement 260AP
1986-03-12Manufacturing (CMC) · Supplement 259AP
1985-12-19Manufacturing (CMC) · Supplement 257AP
1985-12-06Manufacturing (CMC) · Supplement 256AP
1985-12-06Manufacturing (CMC) · Supplement 255AP
1985-12-06Manufacturing (CMC) · Supplement 251AP
1985-09-11Manufacturing (CMC) · Supplement 254AP
1984-12-21Manufacturing (CMC) · Supplement 252AP
1984-07-27Manufacturing (CMC) · Supplement 250AP
1984-03-15Manufacturing (CMC) · Supplement 249AP
1983-12-16Manufacturing (CMC) · Supplement 248AP
1983-12-12Manufacturing (CMC) · Supplement 239AP
1982-06-18Manufacturing (CMC) · Supplement 244AP
1976-11-16OriginalAP
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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