APPLICATION
ANDA085817
TYPE
ANDA
ORIGINAL APPROVAL
1978-08-15
LATEST ACTION
1993-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG · TABLET · ORAL
Approval history
1993-06-28Labeling · Supplement 34AP
1991-12-17Labeling · Supplement 33AP
1988-04-14Labeling · Supplement 28AP
1978-08-15OriginalAP
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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