Details for New Drug Application (NDA): 214640
NDA 214640 describes LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Xiromed and is included in one NDA. It is available from one supplier. Additional details are available on the LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.
The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; levonorgestrel. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
The generic ingredient in LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; levonorgestrel. There is one drug master file entry for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; levonorgestrel profile page.
Summary for 214640
| Tradename: | LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; levonorgestrel |
| Patents: | 0 |
Suppliers and Packaging for NDA: 214640
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LEVONORGESTREL AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; levonorgestrel | TABLET;ORAL | 214640 | ANDA | Xiromed, LLC | 70700-177 | 70700-177-85 | 3 BLISTER PACK in 1 CARTON (70700-177-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;0.1MG | ||||
| Approval Date: | Aug 16, 2023 | TE: | AB3 | RLD: | No | ||||
Complete Access Available with Subscription
