Details for New Drug Application (NDA): 203371
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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 203371
Tradename: | NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
Applicant: | Xiromed |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 203371
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, CHEWABLE;ORAL | 203371 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7308 | 0378-7308-53 | 3 POUCH in 1 CARTON (0378-7308-53) / 1 KIT in 1 POUCH (0378-7308-85) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, CHEWABLE;ORAL | Strength | 0.025MG;0.8MG | ||||
Approval Date: | Apr 23, 2014 | TE: | AB | RLD: | No |
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