BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Medtronic
US Department of Justice
Farmers Insurance
AstraZeneca
Federal Trade Commission
US Army
Cerilliant
Chubb

Generated: January 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091247

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NDA 091247 describes PIMTREA, which is a drug marketed by Novast Labs Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the PIMTREA profile page.

The generic ingredient in PIMTREA is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.
Summary for 091247
Tradename:PIMTREA
Applicant:Novast Labs Ltd
Ingredient:desogestrel; ethinyl estradiol
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 091247
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PIMTREA desogestrel; ethinyl estradiol TABLET;ORAL-28 091247 ANDA Northstar Rx LLC 16714-404 16714-404-03 3 BLISTER PACK in 1 CARTON (16714-404-03) > 1 KIT in 1 BLISTER PACK
PIMTREA desogestrel; ethinyl estradiol TABLET;ORAL-28 091247 ANDA Northstar Rx LLC 16714-404 16714-404-04 6 BLISTER PACK in 1 CARTON (16714-404-04) > 1 KIT in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORAL-28Strength0.15MG,N/A;0.02MG,0.01MG
Approval Date:Aug 1, 2013TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
Argus Health
Cipla
Novartis
Covington
US Department of Justice
Medtronic
Mallinckrodt

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