← FDA DRUG APPROVALS

FDA NDA · NDA204061

RIVELSA

levonorgestrel/ethinyl estradiol and ethinyl estradiol

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA204061
TYPE
NDA
ORIGINAL APPROVAL
2013-03-28
LATEST ACTION
2022-08-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

QUARTETTE · ReferencePrescription
ETHINYL ESTRADIOL 0.02MG,0.15MG, LEVONORGESTREL 0.025MG,0.15MG · TABLET · ORAL

Approval history

2022-08-04Labeling · Supplement 5 · standard — Letter ↗AP
2022-08-04Labeling · Supplement 6 · standard — Letter ↗AP
2022-04-29Labeling · Supplement 8 · standard — Label ↗AP
2017-08-09Labeling · Supplement 2 · standard — Label ↗AP
2013-03-28Type 5 - New Formulation or New Manufacturer · Original · standard — Summary Review ↗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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