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FDA ANDA · ANDA086002

AMITRIPTYLINE HYDROCHLORIDE

Sponsor: ROXANE

APPLICATION
ANDA086002
TYPE
ANDA
ORIGINAL APPROVAL
1977-10-03
LATEST ACTION
1993-08-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

1993-08-24Labeling · Supplement 27AP
1993-03-11Labeling · Supplement 26AP
1991-04-26Labeling · Supplement 25AP
1988-03-30Labeling · Supplement 21AP
1977-10-03OriginalAP
VIEW ON DRUGS@FDA ↗

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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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