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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Cantor Fitzgerald
Harvard Business School
Teva
Cipla
Deloitte
US Army
QuintilesIMS
UBS
Medtronic

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203448

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NDA 203448 describes KAITLIB FE, 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 KAITLIB FE profile page.

The generic ingredient in KAITLIB FE 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 203448
Tradename:KAITLIB FE
Applicant:Lupin Ltd
Ingredient:ethinyl estradiol; norethindrone
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 203448
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KAITLIB FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203448 ANDA LUPIN LIMITED 57297-903 57297-903-13 3 BLISTER PACK in 1 CARTON (57297-903-13) > 1 KIT in 1 BLISTER PACK (57297-903-11)
KAITLIB FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 203448 ANDA Lupin Pharmaceuticals, Inc. 68180-903 68180-903-13 3 BLISTER PACK in 1 CARTON (68180-903-13) > 1 KIT in 1 BLISTER PACK (68180-903-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, CHEWABLE;ORALStrength0.025MG;0.8MG
Approval Date:Dec 17, 2015TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Novartis
Colorcon
US Army
Dow
Julphar
QuintilesIMS
Fish and Richardson
Federal Trade Commission
Healthtrust

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