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Generated: August 23, 2017

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 Mylan, Watson Labs Inc, Ranbaxy Labs Ltd, Sandoz, and Amneal Pharms, and is included in five NDAs. It is available from thirteen 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 nineteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for NDA: 077066

Tradename:
1
Applicant:
1
Ingredient:
1
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 0185-0122-01 100 CAPSULE in 1 BOTTLE (0185-0122-01)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
nitrofurantoin; nitrofurantoin, macrocrystalline
CAPSULE;ORAL 077066 ANDA Eon Labs, Inc. 0185-0122 0185-0122-10 1000 CAPSULE in 1 BOTTLE (0185-0122-10)

Summary for product number 001

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


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