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Last Updated: March 28, 2024

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 one supplier. Additional details are available on the NIKKI profile page.

The generic ingredient in NIKKI is drospirenone; ethinyl estradiol. There are eleven 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 201661
Tradename:NIKKI
Applicant:Lupin Ltd
Ingredient:drospirenone; ethinyl estradiol
Patents:0
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 Pharmaceuticals, Inc. 68180-886 68180-886-73 3 BLISTER PACK in 1 CARTON (68180-886-73) / 1 KIT in 1 BLISTER PACK

Profile for product number 001

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

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