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FDA NDA · NDA209478

SPIRONOLACTONE

Sponsor: CMP DEV LLC

APPLICATION
NDA209478
TYPE
NDA
ORIGINAL APPROVAL
2017-08-04
LATEST ACTION
2023-08-24
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

CAROSPIR · ReferencePrescription
SPIRONOLACTONE 25MG/5ML · SUSPENSION · ORAL

Approval history

2023-08-24Labeling · Supplement 6 · standard — Letter ↗AP
2021-07-15Manufacturing (CMC) · Supplement 2 — Letter ↗AP
2021-06-25Labeling · Supplement 3 · standard — Label ↗AP
2017-08-04Type 3 - New Dosage Form · Original · standard — Label ↗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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