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FDA ANDA · ANDA085745

AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA085745
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 50MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 88AP
1995-10-16Labeling · Supplement 87AP
1994-12-23Manufacturing (CMC) · Supplement 86AP
1994-10-11Manufacturing (CMC) · Supplement 85AP
1993-09-03Labeling · Supplement 84AP
1992-04-03Manufacturing (CMC) · Supplement 83AP
1992-04-03Manufacturing (CMC) · Supplement 81AP
1992-01-31Labeling · Supplement 80AP
1991-12-30Labeling · Supplement 79AP
1990-02-28Manufacturing (CMC) · Supplement 77AP
1990-02-28Manufacturing (CMC) · Supplement 75AP
1990-02-28Manufacturing (CMC) · Supplement 78AP
1990-02-28Labeling · Supplement 76AP
1987-09-29Manufacturing (CMC) · Supplement 73AP
1987-09-29Manufacturing (CMC) · Supplement 71AP
1987-09-29Manufacturing (CMC) · Supplement 72AP
1987-03-20Manufacturing (CMC) · Supplement 70AP
1985-08-12Manufacturing (CMC) · Supplement 65AP
1985-08-12Manufacturing (CMC) · Supplement 63AP
1985-08-12Manufacturing (CMC) · Supplement 66AP
1985-08-12Manufacturing (CMC) · Supplement 64AP
1982-05-11Manufacturing (CMC) · Supplement 47AP
1982-05-11Manufacturing (CMC) · Supplement 46AP
1977-07-11OriginalAP
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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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