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FDA ANDA · ANDA087999
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
Sponsor: PUREPAC PHARM
APPLICATION
ANDA087999
TYPE
ANDA
ORIGINAL APPROVAL
1985-11-06
LATEST ACTION
1989-10-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEDiscontinued
HYDROCHLOROTHIAZIDE 25MG, SPIRONOLACTONE 25MG · TABLET · ORAL
Approval history
1989-10-02Labeling · Supplement 5AP
1988-03-15Labeling · Supplement 4AP
1985-11-06OriginalAP
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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