← FDA DRUG APPROVALS

FDA NDA · NDA214154

NEXTSTELLIS

drospirenone and estetrol

Sponsor: MAYNE PHARMA

APPLICATION
NDA214154
TYPE
NDA
ORIGINAL APPROVAL
2021-04-15
LATEST ACTION
2022-04-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NEXTSTELLIS · ReferencePrescription
DROSPIRENONE 3MG, ESTETROL 14.2MG · TABLET · ORAL

Approval history

2022-04-29Labeling · Supplement 2 · standard — Label ↗AP
2021-04-15Type 1 - New Molecular Entity and Type 4 - New Combination · Original · standard — Label ↗AP
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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