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Fuji
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Federal Trade Commission
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Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206679

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NDA 206679 describes FLOLIPID, which is a drug marketed by Tcg Fluent Pharma and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the FLOLIPID profile page.

The generic ingredient in FLOLIPID is simvastatin. There are thirty-nine drug master file entries for this compound. Sixty-five suppliers are listed for this compound. Additional details are available on the simvastatin profile page.
Summary for 206679
Tradename:FLOLIPID
Applicant:Tcg Fluent Pharma
Ingredient:simvastatin
Patents:1
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 206679
Suppliers and Packaging for NDA: 206679
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLOLIPID simvastatin SUSPENSION;ORAL 206679 NDA Salerno Pharmaceuticals Co. 29273-401 N 29273-401-04
FLOLIPID simvastatin SUSPENSION;ORAL 206679 NDA Salerno Pharmaceuticals Co. 29273-402 N 29273-402-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength20MG/5ML
Approval Date:Apr 21, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 23, 2030Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION;ORALStrength40MG/5ML
Approval Date:Apr 21, 2016TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 23, 2030Product Flag?YSubstance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Mallinckrodt
McKesson
Johnson and Johnson
Cerilliant
Fish and Richardson
Moodys
McKinsey
Chubb

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