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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 204704


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NDA 204704 describes ETHYNODIOL DIACETATE AND ETHINYL ESTRADIOL, which is a drug marketed by Xiromed 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.
Summary for 204704
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:RXDosage:TABLET;ORAL-28Strength0.05MG;1MG
Approval Date:Feb 9, 2016TE:ABRLD:No

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