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Generated: January 23, 2019

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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 four 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. Thirty-one suppliers are listed for this compound. Additional details are available on the levonorgestrel profile page.
Summary for 201446
Applicant:Lupin Ltd
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 LUPIN LIMITED 57297-853 57297-853-13 1 BLISTER PACK in 1 CARTON (57297-853-13) > 1 TABLET in 1 BLISTER PACK (57297-853-11)
FALLBACK SOLO levonorgestrel TABLET;ORAL 201446 ANDA Syzygy Healthcare Solutions, LLC PO Box 588, Westport, CT 06880 64122-605 64122-605-01 1 TABLET in 1 BLISTER PACK (64122-605-01)

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:

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Fish and Richardson
Queensland Health

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