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Serving 500+ biopharmaceutical companies globally:

Queensland Health
Express Scripts
US Department of Justice
Daiichi Sankyo
Chinese Patent Office
Federal Trade Commission

Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091095

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NDA 091095 describes NITROFURANTOIN, which is a drug marketed by Elkins Sinn, Sun Pharm Inds, Mylan, Watson Labs, Sandoz, Impax Labs Inc, Nostrum Labs Inc, Ivax Sub Teva Pharms, Amneal Pharms, Actavis Mid Atlantic, Whiteworth Town Plsn, Novel Labs Inc, Actavis Labs Fl Inc, Watson Labs Inc, and Ranbaxy Labs Ltd, and is included in twenty-seven NDAs. It is available from twenty-three suppliers. Additional details are available on the NITROFURANTOIN profile page.

The generic ingredient in NITROFURANTOIN is nitrofurantoin; nitrofurantoin, macrocrystalline. There are nineteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.

Summary for NDA: 091095

Formulation / Manufacturing:see details

Pharmacology for NDA: 091095


Suppliers and Packaging for NDA: 091095

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
nitrofurantoin, macrocrystalline
CAPSULE;ORAL 091095 ANDA Actavis Pharma, Inc. 0591-3684 0591-3684-01 100 CAPSULE in 1 BOTTLE (0591-3684-01)
nitrofurantoin, macrocrystalline
CAPSULE;ORAL 091095 ANDA Actavis Pharma, Inc. 0591-3684 0591-3684-10 1000 CAPSULE in 1 BOTTLE (0591-3684-10)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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

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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Federal Trade Commission
Harvard Business School
Cantor Fitzgerald
Chinese Patent Office

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