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Generated: March 19, 2019

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Details for New Drug Application (NDA): 077025

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NDA 077025 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-four suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 077025
Tradename:NITROFURANTOIN
Applicant:Mylan
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 077025
Suppliers and Packaging for NDA: 077025
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 077025 ANDA Mylan Pharmaceuticals Inc. 0378-1700 0378-1700-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-1700-01)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 077025 ANDA Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 35356-681 35356-681-00 100 CAPSULE in 1 BOTTLE, PLASTIC (35356-681-00)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Aug 18, 2004TE:ABRLD:No

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