Details for New Drug Application (NDA): 209609
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The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 209609
Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE |
Applicant: | Xiromed |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 209609
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 209609 | ANDA | Xiromed, LLC | 70700-101 | 70700-101-85 | 3 BLISTER PACK in 1 CARTON (70700-101-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.02MG;1MG | ||||
Approval Date: | Jul 16, 2018 | TE: | AB | RLD: | No |
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