Details for New Drug Application (NDA): 200486
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NDA 200486 describes NORETHINDRONE AND ETHINYL ESTRADIOL, which is a drug marketed by Watson Labs, Watson Pharms Teva, Dr Reddys Labs Sa, Mylan Labs Ltd, Naari Pte Ltd, Watson Labs Teva, Xiromed, Teva Branded Pharm, Amneal Pharms, Barr, and Lupin Ltd, and is included in twenty-four NDAs. It is available from one supplier. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL profile page.
The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL 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 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 200486
| Tradename: | NORETHINDRONE AND ETHINYL ESTRADIOL |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | ||||
| Approval Date: | Dec 28, 2015 | TE: | RLD: | No | |||||
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