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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Harvard Business School

Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072693

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NDA 072693 describes NORTREL 1/35-21, which is a drug marketed by Barr and is included in one NDA. It is available from one supplier. Additional details are available on the NORTREL 1/35-21 profile page.

The generic ingredient in NORTREL 1/35-21 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 072693
Tradename:NORTREL 1/35-21
Ingredient:ethinyl estradiol; norethindrone
Formulation / Manufacturing:see details
Pharmacology for NDA: 072693
Ingredient-typeProgesterone Congeners
Mechanism of ActionEstrogen Receptor Agonists
Suppliers and Packaging for NDA: 072693
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTREL 1/35-21 ethinyl estradiol; norethindrone TABLET;ORAL-21 072693 ANDA Teva Pharmaceuticals USA, Inc. 0555-9009 0555-9009-42 3 POUCH in 1 CARTON (0555-9009-42) > 1 BLISTER PACK in 1 POUCH (0555-9009-80) > 21 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-21Strength0.035MG;1MG
Approval Date:Feb 28, 1992TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Fish and Richardson
US Department of Justice

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