Details for New Drug Application (NDA): 204703
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NDA 204703 describes ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Mylan Labs Ltd and is included in two NDAs. It is available from one supplier. Additional details are available on the ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL profile page.
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.
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 204703
| Tradename: | ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL |
| Applicant: | Mylan Labs Ltd |
| Ingredient: | ethinyl estradiol; ethynodiol diacetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 204703
| 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 | 204703 | ANDA | Mylan Pharmaceuticals Inc. | 0378-7307 | 0378-7307-53 | 3 POUCH in 1 CARTON (0378-7307-53) / 1 BLISTER PACK in 1 POUCH (0378-7307-85) / 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: | Jul 28, 2016 | TE: | AB | RLD: | No | ||||
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