Details for New Drug Application (NDA): 207056
✉ Email this page to a colleague
The generic ingredient in NYLIA 1/35 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 207056
Tradename: | NYLIA 1/35 |
Applicant: | Aurobindo Pharma |
Ingredient: | ethinyl estradiol; norethindrone |
Patents: | 0 |
Suppliers and Packaging for NDA: 207056
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NYLIA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207056 | ANDA | Aurobindo Pharma Limited | 65862-898 | 65862-898-88 | 3 POUCH in 1 CARTON (65862-898-88) / 1 BLISTER PACK in 1 POUCH (65862-898-28) / 1 KIT in 1 BLISTER PACK |
NYLIA 1/35 | ethinyl estradiol; norethindrone | TABLET;ORAL-28 | 207056 | ANDA | Aurobindo Pharma Limited | 65862-898 | 65862-898-92 | 6 POUCH in 1 CARTON (65862-898-92) / 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;1MG | ||||
Approval Date: | Oct 21, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription