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Generated: May 29, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077182

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NDA 077182 describes DESOGESTREL AND ETHINYL ESTRADIOL, which is a drug marketed by Watson Labs, Mayne Pharma, Novast Labs Ltd, Aurobindo Pharma Ltd, Duramed Pharms Barr, and Mylan Labs Ltd, and is included in eight NDAs. It is available from nine suppliers. Additional details are available on the DESOGESTREL AND ETHINYL ESTRADIOL profile page.

The generic ingredient in DESOGESTREL AND ETHINYL ESTRADIOL is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 077182

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077182

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
desogestrel; ethinyl estradiol
TABLET;ORAL-28 077182 ANDA Watson Pharma, Inc. 52544-959 52544-959-31 3 BLISTER PACK in 1 CARTON (52544-959-31) > 1 KIT in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
Approval Date:Jan 24, 2006TE:ABRLD:No

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