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FDA ANDA · ANDA072539
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
Sponsor: WATSON LABS
APPLICATION
ANDA072539
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 10MG, PERPHENAZINE 2MG · TABLET · ORAL
Approval history
1996-04-11Labeling · Supplement 5AP
1993-11-04Labeling · Supplement 4AP
1989-05-31Labeling · Supplement 1AP
1989-02-15OriginalAP
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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