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FDA ANDA · ANDA072134

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA072134
TYPE
ANDA
ORIGINAL APPROVAL
1989-02-15
LATEST ACTION
1996-04-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDEDiscontinued
AMITRIPTYLINE HYDROCHLORIDE 25MG, PERPHENAZINE 4MG · TABLET · ORAL

Approval history

1996-04-11Labeling · Supplement 5AP
1993-11-04Labeling · Supplement 4AP
1989-05-31Labeling · Supplement 1AP
1989-02-15OriginalAP
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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