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Serving leading biopharmaceutical companies globally:

Julphar
Novartis
UBS
Farmers Insurance
Citi
AstraZeneca
Moodys
Merck
QuintilesIMS
Harvard Business School

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091332

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NDA 091332 describes NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Apil, Barr, Lupin Ltd, and Mylan Labs Ltd, and is included in seven NDAs. It is available from five suppliers. There is one patent protecting this drug. Additional details are available on the NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE profile page.

The generic ingredient in NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE is ethinyl estradiol; norethindrone. There are twenty-six drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.
Summary for 091332
Tradename:NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
Applicant:Lupin Ltd
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091332
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 091332 ANDA Lupin Pharmaceuticals, Inc. 68180-873 68180-873-13 3 POUCH in 1 CARTON (68180-873-13) > 1 BLISTER PACK in 1 POUCH (68180-873-11) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.035MG;0.4MG
Approval Date:Mar 23, 2016TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Cerilliant
UBS
Argus Health
Accenture
Cipla
Merck
Fish and Richardson
QuintilesIMS

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