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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Baxter
Harvard Business School
Accenture
Colorcon
Medtronic
UBS
Cipla
Queensland Health

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201446

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NDA 201446 describes FALLBACK SOLO, which is a drug marketed by Lupin Ltd and is included in one NDA. It is available from three suppliers. Additional details are available on the FALLBACK SOLO profile page.

The generic ingredient in FALLBACK SOLO is levonorgestrel. There are twenty drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 201446
Tradename:FALLBACK SOLO
Applicant:Lupin Ltd
Ingredient:levonorgestrel
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 201446
Suppliers and Packaging for NDA: 201446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FALLBACK SOLO levonorgestrel TABLET;ORAL 201446 ANDA Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 64122-605 N 64122-605-01
FALLBACK SOLO levonorgestrel TABLET;ORAL 201446 ANDA NuCare Pharmaceuticals,Inc. 68071-4294 N 68071-4294-1

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength1.5MG
Approval Date:Jun 19, 2014TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
UBS
Mallinckrodt
Deloitte
Cerilliant
Cipla
Chubb
US Army
US Department of Justice

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