Details for New Drug Application (NDA): 214594
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NDA 214594 describes ETHINYL ESTRADIOL AND NORELGESTROMIN, which is a drug marketed by Amneal and Zydus Noveltech Inc and is included in two NDAs. It is available from six suppliers. Additional details are available on the ETHINYL ESTRADIOL AND NORELGESTROMIN profile page.
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.
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 214594
| Tradename: | ETHINYL ESTRADIOL AND NORELGESTROMIN |
| Applicant: | Zydus Noveltech Inc |
| Ingredient: | ethinyl estradiol; norelgestromin |
| Patents: | 0 |
Pharmacology for NDA: 214594
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 214594
| 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 | 214594 | ANDA | Zydus Pharmaceuticals USA Inc. | 70710-1190 | 70710-1190-3 | 3 POUCH in 1 CARTON (70710-1190-3) / 1 POUCH in 1 POUCH (70710-1190-1) / 7 mg in 1 POUCH |
| ETHINYL ESTRADIOL AND NORELGESTROMIN | ethinyl estradiol; norelgestromin | FILM, EXTENDED RELEASE;TRANSDERMAL | 214594 | ANDA | Zydus Lifesciences Limited | 70771-1777 | 70771-1777-3 | 3 POUCH in 1 CARTON (70771-1777-3) / 1 POUCH in 1 POUCH (70771-1777-1) / 7 mg in 1 POUCH |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FILM, EXTENDED RELEASE;TRANSDERMAL | Strength | 0.035MG/24HR;0.15MG/24HR | ||||
| Approval Date: | Sep 14, 2023 | TE: | AB | RLD: | No | ||||
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