APPLICATION
ANDA085032
TYPE
ANDA
ORIGINAL APPROVAL
1976-11-19
LATEST ACTION
2016-04-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
Approval history
2016-04-25Labeling · Supplement 309 · standardAP
2014-11-17Labeling · Supplement 308 · standardAP
1997-06-18Manufacturing (CMC) · Supplement 307AP
1995-07-11Labeling · Supplement 306AP
1995-02-16Manufacturing (CMC) · Supplement 304AP
1995-02-15Manufacturing (CMC) · Supplement 305AP
1994-11-30Manufacturing (CMC) · Supplement 303AP
1994-09-06Manufacturing (CMC) · Supplement 302AP
1994-06-17Manufacturing (CMC) · Supplement 301AP
1994-03-23Manufacturing (CMC) · Supplement 300AP
1993-08-18Labeling · Supplement 299AP
1992-06-12Labeling · Supplement 298AP
1992-06-10Manufacturing (CMC) · Supplement 294AP
1991-12-31Labeling · Supplement 295AP
1989-04-05Manufacturing (CMC) · Supplement 293AP
1989-04-05Manufacturing (CMC) · Supplement 292AP
1988-03-31Manufacturing (CMC) · Supplement 290AP
1987-11-04Manufacturing (CMC) · Supplement 287AP
1987-09-30Manufacturing (CMC) · Supplement 285AP
1987-09-30Manufacturing (CMC) · Supplement 288AP
1987-09-30Manufacturing (CMC) · Supplement 280AP
1986-04-28Manufacturing (CMC) · Supplement 283AP
1986-04-28Manufacturing (CMC) · Supplement 284AP
1986-03-12Manufacturing (CMC) · Supplement 281AP
1986-03-12Manufacturing (CMC) · Supplement 282AP
1985-12-06Manufacturing (CMC) · Supplement 279AP
1985-12-06Manufacturing (CMC) · Supplement 275AP
1985-09-11Manufacturing (CMC) · Supplement 278AP
1984-12-21Manufacturing (CMC) · Supplement 276AP
1984-07-27Manufacturing (CMC) · Supplement 274AP
1984-03-15Manufacturing (CMC) · Supplement 273AP
1983-12-16Manufacturing (CMC) · Supplement 271AP
1983-12-12Manufacturing (CMC) · Supplement 263AP
1983-02-28Manufacturing (CMC) · Supplement 270AP
1976-11-19OriginalAP
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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