Details for New Drug Application (NDA): 213950
✉ Email this page to a colleague
The generic ingredient in ETHINYL ESTRADIOL AND NORELGESTROMIN is ethinyl estradiol; norelgestromin. There are twenty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norelgestromin profile page.
Summary for 213950
Tradename: | ETHINYL ESTRADIOL AND NORELGESTROMIN |
Applicant: | Amneal |
Ingredient: | ethinyl estradiol; norelgestromin |
Patents: | 0 |
Pharmacology for NDA: 213950
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 213950
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 213950 | ANDA | AvKARE | 42291-930 | 42291-930-03 | 3 POUCH in 1 CARTON (42291-930-03) / 1 PATCH in 1 POUCH (42291-930-01) / 7 d in 1 PATCH |
ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 213950 | ANDA | Amneal Pharmaceuticals LLC | 65162-358 | 65162-358-03 | 3 POUCH in 1 CARTON (65162-358-03) / 1 PATCH in 1 POUCH (65162-358-01) / 7 d in 1 PATCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.035MG/24HR;0.15MG/24HR | ||||
Approval Date: | Feb 25, 2021 | TE: | AB | RLD: | No |
Complete Access Available with Subscription