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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Queensland Health
US Army
Fish and Richardson

Generated: January 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206287

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NDA 206287 describes MIBELAS 24 FE, which is a drug marketed by Lupin Atlantis and is included in one NDA. It is available from one supplier. Additional details are available on the MIBELAS 24 FE profile page.

The generic ingredient in MIBELAS 24 FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.
Summary for 206287
Tradename:MIBELAS 24 FE
Applicant:Lupin Atlantis
Ingredient:ethinyl estradiol; norethindrone acetate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 206287
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MIBELAS 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 206287 ANDA Lupin Pharmaceuticals, Inc. 68180-911 68180-911-13 3 POUCH in 1 CARTON (68180-911-13) > 1 BLISTER PACK in 1 POUCH (68180-911-11) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.02MG;1MG
Approval Date:May 24, 2016TE:ABRLD:No
Regulatory Exclusivity Expiration:Sep 11, 2017
Regulatory Exclusivity Use:PATENT CHALLENGE

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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Boehringer Ingelheim
Fish and Richardson
Queensland Health
Daiichi Sankyo

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