Details for New Drug Application (NDA): 076221
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The generic ingredient in NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 076221
Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL |
Applicant: | Barr Labs Inc |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Pharmacology for NDA: 076221
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 076221
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 076221 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3122 | 0093-3122-42 | 5 BLISTER PACK in 1 CARTON (0093-3122-42) / 28 TABLET in 1 BLISTER PACK (0093-3122-28) |
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone acetate | TABLET;ORAL | 076221 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3122 | 0093-3122-98 | 90 TABLET in 1 BOTTLE (0093-3122-98) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.005MG;1MG | ||||
Approval Date: | Nov 6, 2009 | TE: | AB | RLD: | No |
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