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Harvard Business School
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Generated: September 22, 2017

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. Nineteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

Summary for NDA: 201887

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201887

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
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
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

Summary 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 500+ biopharmaceutical companies globally:

Queensland Health
Johnson and Johnson
US Department of Justice
Cantor Fitzgerald
Fish and Richardson

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