Details for New Drug Application (NDA): 206864
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NDA 206864 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 206864
| Tradename: | NORETHINDRONE AND ETHINYL ESTRADIOL |
| Applicant: | Naari Pte Ltd |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 206864
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NORETHINDRONE AND ETHINYL ESTRADIOL | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 206864 | ANDA | Naari Pte Limited | 79929-007 | 79929-007-07 | 3 BLISTER PACK in 1 CARTON (79929-007-07) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;1MG | ||||
| Approval Date: | Apr 28, 2017 | TE: | AB | RLD: | No | ||||
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