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Serving leading biopharmaceutical companies globally:

US Army
Fish and Richardson
Chinese Patent Office
Argus Health
Farmers Insurance

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201887

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NDA 201887 describes ENSKYCE, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the ENSKYCE profile page.

The generic ingredient in ENSKYCE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 201887
Applicant:Lupin Ltd
Ingredient:desogestrel; ethinyl estradiol
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201887
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENSKYCE desogestrel; ethinyl estradiol TABLET;ORAL-28 201887 ANDA LUPIN LIMITED 57297-882 57297-882-13 3 POUCH in 1 CARTON (57297-882-13) > 1 BLISTER PACK in 1 POUCH (57297-882-11) > 1 KIT in 1 BLISTER PACK
ENSKYCE desogestrel; ethinyl estradiol TABLET;ORAL-28 201887 ANDA Lupin Pharmaceuticals, Inc. 68180-882 68180-882-13 3 POUCH in 1 CARTON (68180-882-13) > 1 BLISTER PACK in 1 POUCH (68180-882-11) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG;0.03MG
Approval Date:Mar 7, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Farmers Insurance
Johnson and Johnson

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