← FDA DRUG APPROVALS

FDA NDA · NDA021840

CAMRESE

levonorgestrel / ethinyl estradiol and ethinyl estradiol

Sponsor: TEVA BRANDED PHARM

APPLICATION
NDA021840
TYPE
NDA
ORIGINAL APPROVAL
2006-05-25
LATEST ACTION
2023-01-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

SEASONIQUE · ReferencePrescription
ETHINYL ESTRADIOL 0.03MG,0.01MG, LEVONORGESTREL 0.15MG,N/A · TABLET · ORAL

Approval history

2023-01-27Labeling · Supplement 13 · standard — Label ↗AP
2023-01-27Labeling · Supplement 12 · standard — Label ↗AP
2022-04-29Labeling · Supplement 15 · standard — Label ↗AP
2017-08-09Labeling · Supplement 11 · standard — Label ↗AP
2014-09-22Manufacturing (CMC) · Supplement 10 · standardAP
2010-07-29Efficacy · Supplement 8 · standard — Letter ↗AP
2006-05-25Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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