Details for New Drug Application (NDA): 204305
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NDA 204305 describes ETHINYL ESTRADIOL; ETONOGESTREL, which is a drug marketed by Teva Pharms Usa Inc and is included in one NDA. It is available from one supplier. Additional details are available on the ETHINYL ESTRADIOL; ETONOGESTREL profile page.
The generic ingredient in ETHINYL ESTRADIOL; ETONOGESTREL 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 ETHINYL ESTRADIOL; ETONOGESTREL 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 204305
| Tradename: | ETHINYL ESTRADIOL; ETONOGESTREL |
| Applicant: | Teva Pharms Usa Inc |
| Ingredient: | ethinyl estradiol; etonogestrel |
| Patents: | 0 |
Pharmacology for NDA: 204305
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 204305
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHINYL ESTRADIOL; ETONOGESTREL | ethinyl estradiol; etonogestrel | RING;VAGINAL | 204305 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-7679 | 0093-7679-02 | 3 POUCH in 1 CARTON (0093-7679-02) / 21 d in 1 POUCH (0093-7679-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | RING;VAGINAL | Strength | 0.015MG/24HR;0.12MG/24HR | ||||
| Approval Date: | Jan 13, 2021 | TE: | AB | RLD: | No | ||||
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