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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 073652


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NDA 073652 describes NITROFURANTOIN, which is a drug marketed by Actavis Labs Fl Inc, Alembic, Athem, Aurobindo Pharma Usa, Impax Labs Inc, Mankind Pharma, Novel Labs Inc, Sun Pharm Industries, Watson Labs, Zydus Pharms, Actavis Mid Atlantic, Amneal Pharms, Aurobindo Pharma, Nostrum Labs Inc, Novitium Pharma, Elkins Sinn, Ivax Sub Teva Pharms, Sandoz, Whiteworth Town Plsn, Alvogen, Inventia, Omsav Pharma, Ranbaxy Labs Ltd, Sunny, and Watson Labs Inc, and is included in thirty-nine NDAs. It is available from thirty-two 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-four suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 073652
Tradename:NITROFURANTOIN
Applicant:Impax Labs Inc
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 073652
Suppliers and Packaging for NDA: 073652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073652 ANDA Amneal Pharmaceuticals of New York LLC 0115-1645 0115-1645-01 100 CAPSULE in 1 BOTTLE (0115-1645-01)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 073652 ANDA Amneal Pharmaceuticals of New York LLC 0115-1645 0115-1645-03 1000 CAPSULE in 1 BOTTLE (0115-1645-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Jan 28, 1993TE:ABRLD:No

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