Details for New Drug Application (NDA): 206864
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, Watson Labs Teva, Xiromed, Teva Branded Pharm, Amneal Pharms, Barr, and Lupin, and is included in twenty-four NDAs. It is available from two suppliers. 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 is one drug master file entry for this compound. Fifteen 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 is one drug master file entry for this compound. Fifteen 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 |
| 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 | Apotex Corp. | 60505-4901 | 60505-4901-8 | 3 BLISTER PACK in 1 CARTON (60505-4901-8) / 1 KIT in 1 BLISTER PACK (60505-4901-2) |
| 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 | ||||
Complete Access Available with Subscription
