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FDA ANDA · ANDA085743

AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA085743
TYPE
ANDA
ORIGINAL APPROVAL
1977-07-11
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 67AP
1995-10-16Labeling · Supplement 66AP
1994-12-23Manufacturing (CMC) · Supplement 65AP
1994-10-11Manufacturing (CMC) · Supplement 64AP
1993-09-03Labeling · Supplement 63AP
1992-04-03Manufacturing (CMC) · Supplement 60AP
1992-04-03Manufacturing (CMC) · Supplement 62AP
1992-01-31Labeling · Supplement 59AP
1991-12-30Labeling · Supplement 58AP
1990-02-28Labeling · Supplement 57AP
1990-02-28Manufacturing (CMC) · Supplement 56AP
1987-09-29Manufacturing (CMC) · Supplement 52AP
1987-09-29Manufacturing (CMC) · Supplement 53AP
1987-09-29Manufacturing (CMC) · Supplement 54AP
1987-03-20Manufacturing (CMC) · Supplement 51AP
1986-02-27Manufacturing (CMC) · Supplement 49AP
1986-02-05Manufacturing (CMC) · Supplement 48AP
1977-07-11OriginalAP
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