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Generated: November 12, 2018

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Details for New Drug Application (NDA): 203233

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NDA 203233 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 203233
Tradename:NITROFURANTOIN
Applicant:Novel Labs Inc
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jul 9, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jul 9, 2018TE:ABRLD:No

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