Details for New Drug Application (NDA): 210830
✉ Email this page to a colleague
NDA 210830 describes ELURYNG, which is a drug marketed by Amneal and is included in one NDA. It is available from one supplier. Additional details are available on the ELURYNG profile page.
The generic ingredient in ELURYNG is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
The generic ingredient in ELURYNG is ethinyl estradiol; etonogestrel. There are twenty-six drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; etonogestrel profile page.
Summary for 210830
| Tradename: | ELURYNG |
| Applicant: | Amneal |
| Ingredient: | ethinyl estradiol; etonogestrel |
| Patents: | 0 |
Pharmacology for NDA: 210830
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 210830
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELURYNG | ethinyl estradiol; etonogestrel | RING;VAGINAL | 210830 | ANDA | Amneal Pharmaceuticals LLC | 65162-469 | 65162-469-35 | 3 POUCH in 1 CARTON (65162-469-35) / 21 d in 1 POUCH (65162-469-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | RING;VAGINAL | Strength | 0.015MG/24HR;0.12MG/24HR | ||||
| Approval Date: | Dec 11, 2019 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
