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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076648

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NDA 076648 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 fifteen 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-three suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 076648
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Mylan
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 076648
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 076648
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076648 ANDA Mylan Pharmaceuticals Inc. 0378-3422 0378-3422-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-3422-01)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 076648 ANDA Mylan Institutional Inc. 51079-348 51079-348-20 100 BLISTER PACK in 1 CARTON (51079-348-20) > 1 CAPSULE in 1 BLISTER PACK (51079-348-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Mar 22, 2004TE:ABRLD:No

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Fish and Richardson
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Chubb
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Federal Trade Commission
Cantor Fitzgerald
Queensland Health
Colorcon

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