BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
US Department of Justice
Harvard Business School
Fish and Richardson
Boehringer Ingelheim
Chinese Patent Office
US Army

Generated: December 12, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202226

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NDA 202226 describes BEKYREE, 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 BEKYREE profile page.

The generic ingredient in BEKYREE 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 202226

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 202226

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BEKYREE desogestrel; ethinyl estradiol TABLET;ORAL-28 202226 ANDA LUPIN LIMITED 57297-880 57297-880-13 3 POUCH in 1 CARTON (57297-880-13) > 1 KIT in 1 POUCH (57297-880-11)
BEKYREE desogestrel; ethinyl estradiol TABLET;ORAL-28 202226 ANDA Lupin Pharmaceuticals, Inc. 68180-880 68180-880-13 3 POUCH in 1 CARTON (68180-880-13) > 1 KIT in 1 POUCH (68180-880-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG,N/A;0.02MG,0.01MG
Approval Date:Aug 12, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Farmers Insurance
Daiichi Sankyo
Express Scripts

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