APPLICATION
ANDA088886
TYPE
ANDA
ORIGINAL APPROVAL
1984-09-26
LATEST ACTION
2001-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
Approval history
2001-06-25Labeling · Supplement 19AP
2000-10-05Labeling · Supplement 17AP
2000-07-07Manufacturing (CMC) · Supplement 16AP
1995-07-14Manufacturing (CMC) · Supplement 14AP
1995-07-14Labeling · Supplement 13AP
1995-05-24Labeling · Supplement 15AP
1994-05-11Manufacturing (CMC) · Supplement 12AP
1993-11-04Labeling · Supplement 11AP
1992-05-26Labeling · Supplement 10AP
1991-07-29Manufacturing (CMC) · Supplement 6AP
1990-10-26Labeling · Supplement 8AP
1990-02-14Bioequivalence · Supplement 7AP
1988-03-22Manufacturing (CMC) · Supplement 5AP
1985-06-17Manufacturing (CMC) · Supplement 2AP
1985-06-17Manufacturing (CMC) · Supplement 3AP
1985-06-17Manufacturing (CMC) · Supplement 1AP
1984-09-26OriginalAP
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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