APPLICATION
ANDA085836
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-02
LATEST ACTION
1997-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 100MG · TABLET · ORAL
Approval history
1997-06-18Manufacturing (CMC) · Supplement 167AP
1995-07-11Labeling · Supplement 166AP
1995-02-16Manufacturing (CMC) · Supplement 164AP
1995-02-15Manufacturing (CMC) · Supplement 165AP
1994-11-30Manufacturing (CMC) · Supplement 163AP
1994-09-06Manufacturing (CMC) · Supplement 162AP
1994-06-17Manufacturing (CMC) · Supplement 161AP
1994-03-23Manufacturing (CMC) · Supplement 160AP
1993-08-18Labeling · Supplement 159AP
1992-06-12Labeling · Supplement 158AP
1992-06-10Manufacturing (CMC) · Supplement 155AP
1991-12-31Labeling · Supplement 156AP
1989-04-05Manufacturing (CMC) · Supplement 153AP
1988-03-31Manufacturing (CMC) · Supplement 151AP
1988-03-31Manufacturing (CMC) · Supplement 152AP
1987-11-04Manufacturing (CMC) · Supplement 148AP
1987-09-30Manufacturing (CMC) · Supplement 149AP
1987-09-30Manufacturing (CMC) · Supplement 146AP
1986-05-09Manufacturing (CMC) · Supplement 145AP
1986-05-09Manufacturing (CMC) · Supplement 144AP
1986-03-12Manufacturing (CMC) · Supplement 142AP
1986-03-12Manufacturing (CMC) · Supplement 143AP
1985-12-06Manufacturing (CMC) · Supplement 140AP
1985-12-06Manufacturing (CMC) · Supplement 137AP
1985-09-11Manufacturing (CMC) · Supplement 139AP
1984-12-21Manufacturing (CMC) · Supplement 138AP
1984-07-27Manufacturing (CMC) · Supplement 136AP
1984-03-15Manufacturing (CMC) · Supplement 135AP
1982-07-07Manufacturing (CMC) · Supplement 130AP
1977-08-02OriginalAP
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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