APPLICATION
ANDA085744
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-21
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 78AP
1995-10-16Labeling · Supplement 77AP
1994-12-23Manufacturing (CMC) · Supplement 76AP
1994-10-11Manufacturing (CMC) · Supplement 75AP
1993-09-03Labeling · Supplement 74AP
1992-04-03Manufacturing (CMC) · Supplement 73AP
1992-04-03Manufacturing (CMC) · Supplement 71AP
1992-01-31Labeling · Supplement 70AP
1991-12-30Labeling · Supplement 69AP
1990-02-28Labeling · Supplement 68AP
1990-02-28Manufacturing (CMC) · Supplement 67AP
1988-02-12Manufacturing (CMC) · Supplement 66AP
1987-03-20Manufacturing (CMC) · Supplement 61AP
1986-03-05Manufacturing (CMC) · Supplement 59AP
1986-03-05Manufacturing (CMC) · Supplement 57AP
1985-12-27Manufacturing (CMC) · Supplement 58AP
1977-06-21OriginalAP
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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