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Generated: November 18, 2018

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Details for New Drug Application (NDA): 091095

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NDA 091095 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 091095
Tradename:NITROFURANTOIN
Applicant:Actavis Labs Fl Inc
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 091095
Ingredient-typeNitrofurans
Suppliers and Packaging for NDA: 091095
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 091095 ANDA Actavis Pharma, Inc. 0591-3684 0591-3684-01 100 CAPSULE in 1 BOTTLE (0591-3684-01)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 091095 ANDA Actavis Pharma, Inc. 0591-3684 0591-3684-10 1000 CAPSULE in 1 BOTTLE (0591-3684-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Jun 18, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Jun 18, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jun 18, 2015TE:ABRLD:No

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