Details for New Drug Application (NDA): 202086
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NDA 202086 describes NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Teva Branded Pharm, Xiromed, Amneal Pharms, Barr, Lupin Ltd, and Naari Pte Ltd, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.
The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 202086
| Tradename: | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
| Applicant: | Xiromed |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 202086
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone | TABLET;ORAL | 202086 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7297 | 0378-7297-53 | 3 POUCH in 1 CARTON (0378-7297-53) / 1 BLISTER PACK in 1 POUCH (0378-7297-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.035MG;0.4MG | ||||
| Approval Date: | Apr 1, 2015 | TE: | AB | RLD: | No | ||||
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