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FDA NDA · NDA021544

JOLESSA

levonorgestrel / ethinyl estradiol

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA021544
TYPE
NDA
ORIGINAL APPROVAL
2003-09-05
LATEST ACTION
2023-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SEASONALE · ReferencePrescription
ETHINYL ESTRADIOL 0.03MG, LEVONORGESTREL 0.15MG · TABLET · ORAL

Approval history

2023-01-27Labeling · Supplement 14 · standard — Label ↗AP
2023-01-27Labeling · Supplement 15 · standard — Label ↗AP
2022-04-29Labeling · Supplement 17 · standard — Label ↗AP
2017-08-09Labeling · Supplement 13 · standard — Label ↗AP
2017-03-31Labeling · Supplement 10 · standard — Letter ↗AP
2017-03-31Labeling · Supplement 9 · standard — Letter ↗AP
2014-11-05Manufacturing (CMC) · Supplement 12 · standardAP
2003-09-05Type 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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