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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Argus Health
Chinese Patent Office
Boehringer Ingelheim
Fish and Richardson
Express Scripts
Cantor Fitzgerald

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200383

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NDA 200383 describes NORGESTIMATE AND ETHINYL ESTRADIOL, which is a drug marketed by Glenmark Generics, Amneal Pharms, Glenmark Pharms, Lupin Ltd, Lupin Pharms, Mylan Labs Ltd, Oc Pharma, and Watson Labs, and is included in seventeen NDAs. It is available from seven suppliers. Additional details are available on the NORGESTIMATE AND ETHINYL ESTRADIOL profile page.

The generic ingredient in NORGESTIMATE AND ETHINYL ESTRADIOL is ethinyl estradiol; norgestimate. There are twenty-six drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norgestimate profile page.

Summary for 200383

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 200383

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORGESTIMATE AND ETHINYL ESTRADIOL ethinyl estradiol; norgestimate TABLET;ORAL-28 200383 ANDA Akorn, Inc. 17478-261 17478-261-06 6 CARTON in 1 CARTON (17478-261-06) > 1 BLISTER PACK in 1 CARTON (17478-261-28) > 1 KIT in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;0.25MG
Approval Date:Apr 7, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Army
US Department of Justice
Express Scripts
Farmers Insurance

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