← FDA DRUG APPROVALS

FDA NDA · NDA022262

CAMRESE LO

levonorgestrel/ethinyl estradiol and ethinyl estradiol

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA022262
TYPE
NDA
ORIGINAL APPROVAL
2008-10-24
LATEST ACTION
2023-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

LOSEASONIQUEPrescription
ETHINYL ESTRADIOL 0.02MG,0.1MG, LEVONORGESTREL 0.01MG,N/A · TABLET · ORAL

Approval history

2023-01-27Labeling · Supplement 3 · standard — Label ↗AP
2023-01-27Labeling · Supplement 4 · standard — Label ↗AP
2022-04-29Labeling · Supplement 6 · standard — Letter ↗AP
2017-08-09Labeling · Supplement 2 · standard — Label ↗AP
2015-04-07Manufacturing (CMC) · Supplement 1 · standardAP
2008-10-24Type 3 - New Dosage Form · Original · standard — 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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