APPLICATION
ANDA075804
TYPE
ANDA
ORIGINAL APPROVAL
2002-09-25
LATEST ACTION
2022-04-29
ROUTE
ORAL-28
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
SPRINTECPrescription
ETHINYL ESTRADIOL 0.035MG, NORGESTIMATE 0.25MG · TABLET · ORAL-28
Approval history
2022-04-29Labeling · Supplement 36 · standardAP
2022-01-28Labeling · Supplement 30 · standardAP
2016-04-13Labeling · Supplement 26 · standardAP
2016-04-13Labeling · Supplement 27 · standardAP
2013-01-31Labeling · Supplement 25 · standardAP
2011-08-31Labeling · Supplement 23AP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.