Details for New Drug Application (NDA): 205069
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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-four suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 205069
Tradename: | NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL |
Applicant: | Mylan |
Ingredient: | ethinyl estradiol; norethindrone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 205069
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-28 | 205069 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7303 | 0378-7303-53 | 3 POUCH in 1 CARTON (0378-7303-53) / 1 BLISTER PACK in 1 POUCH (0378-7303-85) / 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK (0378-7191-71) * 9 TABLET in 1 BLISTER PACK (0378-7192-59) * 7 TABLET in 1 BLISTER PACK (0378-7193-71) * 5 TABLET in 1 BLISTER PACK (0378-7190-98) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG | ||||
Approval Date: | Jun 22, 2018 | TE: | AB | RLD: | No |
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