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Generated: November 15, 2018

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Details for New Drug Application (NDA): 205005

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NDA 205005 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Impax Labs Inc, Mylan, Novel Labs Inc, Sandoz, Sun Pharm Industries, Watson Labs, Zydus Pharms Usa Inc, Actavis Mid Atlantic, Amneal Pharms, Nostrum Labs Inc, Elkins Sinn, Ivax Sub Teva Pharms, Whiteworth Town Plsn, Ranbaxy Labs Ltd, Sunny Pharmtech Inc, and Watson Labs Inc, and is included in thirty NDAs. It is available from twenty-five suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-six suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 205005
Tradename:NITROFURANTOIN
Applicant:Zydus Pharms Usa Inc
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205005
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 205005
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 205005 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-559 68382-559-01 100 CAPSULE in 1 BOTTLE (68382-559-01)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 205005 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-559 68382-559-10 1000 CAPSULE in 1 BOTTLE (68382-559-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 12, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 12, 2017TE:ABRLD:No

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