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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Farmers Insurance
Daiichi Sankyo
McKinsey
Cipla
Healthtrust
Fish and Richardson
Cerilliant
Merck

Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202250

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NDA 202250 describes NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), which is a drug marketed by Amneal Pharms, Mylan, Ranbaxy Labs Ltd, Sandoz, and Watson Labs Inc, and is included in five NDAs. It is available from seventeen suppliers. Additional details are available on the NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) profile page.

The generic ingredient in NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 202250
Pharmacology for NDA: 202250
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 202250
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 202250 ANDA Actavis Pharma, Inc. 0591-3658 N 0591-3658-30
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 202250 ANDA Actavis Pharma, Inc. 0591-3658 N 0591-3658-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Jul 8, 2015TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Healthtrust
Teva
Deloitte
Queensland Health
Citi
Cipla
UBS
US Department of Justice

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