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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Argus Health

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201661

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NDA 201661 describes NIKKI, 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 NIKKI profile page.

The generic ingredient in NIKKI is drospirenone; ethinyl estradiol. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for 201661

Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 201661

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NIKKI drospirenone; ethinyl estradiol TABLET;ORAL 201661 ANDA LUPIN LIMITED 57297-886 57297-886-13 3 BLISTER PACK in 1 CARTON (57297-886-13) > 1 KIT in 1 BLISTER PACK (57297-886-11)
NIKKI drospirenone; ethinyl estradiol TABLET;ORAL 201661 ANDA Lupin Pharmaceuticals, Inc. 68180-886 68180-886-13 3 BLISTER PACK in 1 CARTON (68180-886-13) > 1 KIT in 1 BLISTER PACK (68180-886-11)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength3MG;0.02MG
Approval Date:May 27, 2014TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Argus Health
Harvard Business School
Cantor Fitzgerald

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