Ethinyl estradiol; norelgestromin
Ethinyl estradiol; norelgestromin: 2 brands, 4 generics; first approved Nov 20, 2001; generic available.
Generic available: 4 ANDA applications approved.
Brand (NDA) products
- VIATRIS SPECIALTYNDA 2199902026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.02MG/24HR;0.22MG/24HR SYSTEM TRANSDERMAL Rx — - ORTHO EVRARLDJANSSEN PHARMSNDA 0211802001
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Discontinued —
Generic (ANDA) products (4)
- ZYDUS PHARMSANDA 2145942023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB - TEVA PHARMS USAANDA 2139772021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB - AMNEALANDA 2139502021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB - XULANERSMYLAN TECHNOLOGIESANDA 2009102014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.035MG/24HR;0.15MG/24HR FILM, EXTENDED RELEASE TRANSDERMAL Rx AB
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2001–2026 across 6 FDA applications.
Ethinyl estradiol; norelgestromin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
