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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Johnson and Johnson
Fuji
Moodys
McKesson
Queensland Health
Deloitte
Healthtrust
Cantor Fitzgerald

Generated: October 22, 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. Fifteen suppliers are listed for this compound. Additional details are available on the drospirenone; ethinyl estradiol profile page.

Summary for NDA: 201661

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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:

Fish and Richardson
Fuji
Covington
Daiichi Sankyo
Dow
QuintilesIMS
Queensland Health
Citi
US Army
Express Scripts

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