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FDA ANDA · ANDA085627

AMITRIPTYLINE HYDROCHLORIDE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA085627
TYPE
ANDA
ORIGINAL APPROVAL
1977-05-10
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 95AP
1995-10-16Labeling · Supplement 94AP
1994-12-23Manufacturing (CMC) · Supplement 93AP
1994-10-11Manufacturing (CMC) · Supplement 92AP
1993-09-03Labeling · Supplement 91AP
1992-04-03Manufacturing (CMC) · Supplement 88AP
1992-04-03Manufacturing (CMC) · Supplement 90AP
1992-01-31Labeling · Supplement 87AP
1991-12-30Labeling · Supplement 86AP
1990-02-28Manufacturing (CMC) · Supplement 84AP
1990-02-28Labeling · Supplement 85AP
1990-02-28Manufacturing (CMC) · Supplement 83AP
1988-02-12Manufacturing (CMC) · Supplement 82AP
1987-09-29Manufacturing (CMC) · Supplement 78AP
1987-09-29Manufacturing (CMC) · Supplement 80AP
1987-09-29Manufacturing (CMC) · Supplement 79AP
1987-03-31Manufacturing (CMC) · Supplement 74AP
1986-07-11Manufacturing (CMC) · Supplement 71AP
1986-03-14Manufacturing (CMC) · Supplement 73AP
1985-08-12Manufacturing (CMC) · Supplement 67AP
1985-08-12Manufacturing (CMC) · Supplement 68AP
1985-08-12Manufacturing (CMC) · Supplement 66AP
1985-08-12Manufacturing (CMC) · Supplement 69AP
1977-05-10OriginalAP
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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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