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Chubb
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Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077066

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NDA 077066 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 077066
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Sandoz
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077066
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 077066
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 077066 ANDA Eon Labs, Inc. 0185-0122 N 0185-0122-01
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 077066 ANDA Eon Labs, Inc. 0185-0122 N 0185-0122-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Apr 5, 2005TE:ABRLD:No

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