Details for New Drug Application (NDA): 204704
✉ Email this page to a colleague
The generic ingredient in ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL is ethinyl estradiol; ethynodiol diacetate. There are twenty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; ethynodiol diacetate profile page.
Summary for 204704
Tradename: | ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL |
Applicant: | Xiromed |
Ingredient: | ethinyl estradiol; ethynodiol diacetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 204704
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL | ethinyl estradiol; ethynodiol diacetate | TABLET;ORAL-28 | 204704 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7306 | 0378-7306-53 | 3 POUCH in 1 CARTON (0378-7306-53) / 1 BLISTER PACK in 1 POUCH (0378-7306-85) / 1 KIT in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL-28 | Strength | 0.05MG;1MG | ||||
Approval Date: | Feb 9, 2016 | TE: | AB | RLD: | No |
Complete Access Available with Subscription