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FDA NDA · NDA216285

DROSPIRENONE

Sponsor: EXELTIS USA INC

APPLICATION
NDA216285
TYPE
NDA
ORIGINAL APPROVAL
2022-06-29
LATEST ACTION
2022-12-19
ROUTE
ORAL
DOSAGE FORM
TABLET, CHEWABLE
MARKETING STATUS
Discontinued

Products

DROSPIRENONE · ReferenceDiscontinued
DROSPIRENONE 3.5MG · TABLET, CHEWABLE · ORAL

Approval history

2022-12-19Labeling · Supplement 2 · standard — Letter ↗AP
2022-06-29Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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