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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Boehringer Ingelheim
US Army

Generated: March 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076784

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NDA 076784 describes TRI LO SPRINTEC, which is a drug marketed by Barr Labs Inc and is included in one NDA. It is available from two suppliers. Additional details are available on the TRI LO SPRINTEC profile page.

The generic ingredient in TRI LO SPRINTEC is ethinyl estradiol; norgestimate. 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; norgestimate profile page.
Summary for 076784
Applicant:Barr Labs Inc
Ingredient:ethinyl estradiol; norgestimate
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 076784
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRI LO SPRINTEC ethinyl estradiol; norgestimate TABLET;ORAL-28 076784 ANDA Teva Pharmaceuticals USA, Inc. 0093-2140 N 0093-2140-62
TRI LO SPRINTEC ethinyl estradiol; norgestimate TABLET;ORAL-28 076784 ANDA Preferred Pharmaceuticals Inc. 68788-7036 N 68788-7036-2

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG
Approval Date:Jun 29, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
US Army

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