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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Johnson and Johnson
US Army

Generated: September 21, 2017

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. Twenty-two suppliers are listed for this compound. Additional details are available on the ethinyl estradiol; norethindrone profile page.

Summary for NDA: 072693

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

Summary 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 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
Express Scripts
Johnson and Johnson
Harvard Business School
Argus Health

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