Details for New Drug Application (NDA): 207055
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NDA 207055 describes CYONANZ, which is a drug marketed by Aurobindo Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the CYONANZ profile page.
The generic ingredient in CYONANZ 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 CYONANZ 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 207055
| Tradename: | CYONANZ |
| Applicant: | Aurobindo Pharma |
| Ingredient: | ethinyl estradiol; norethindrone |
| Patents: | 0 |
Suppliers and Packaging for NDA: 207055
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CYONANZ | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207055 | ANDA | Aurobindo Pharma Limited | 65862-899 | 65862-899-88 | 3 POUCH in 1 CARTON (65862-899-88) / 1 BLISTER PACK in 1 POUCH (65862-899-28) / 1 KIT in 1 BLISTER PACK |
| CYONANZ | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207055 | ANDA | Aurobindo Pharma Limited | 65862-899 | 65862-899-92 | 6 POUCH in 1 CARTON (65862-899-92) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.035MG;0.5MG | ||||
| Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No | ||||
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