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FDA ANDA · ANDA086454

AMITID

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APPLICATION
ANDA086454
TYPE
ANDA
ORIGINAL APPROVAL
1978-10-19
LATEST ACTION
1978-10-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

AMITIDDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 75MG · TABLET · ORAL
AMITIDDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
AMITIDDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 100MG · TABLET · ORAL
AMITIDDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 50MG · TABLET · ORAL
AMITIDDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 10MG · TABLET · ORAL

Approval history

1978-10-19OriginalAP
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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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