Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Farmers Insurance
Chubb
Teva
Boehringer Ingelheim
UBS
Accenture
Cantor Fitzgerald
Julphar

Generated: January 19, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205005

« Back to Dashboard

NDA 205005 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 205005
Tradename:NITROFURANTOIN
Applicant:Zydus Pharms Usa Inc
Ingredient:nitrofurantoin, macrocrystalline
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205005
Suppliers and Packaging for NDA: 205005
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 205005 ANDA NuCare Pharmaceuticals,Inc. 68071-4688 68071-4688-7 14 CAPSULE in 1 BOTTLE (68071-4688-7)
NITROFURANTOIN nitrofurantoin, macrocrystalline CAPSULE;ORAL 205005 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-559 68382-559-01 100 CAPSULE in 1 BOTTLE (68382-559-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength50MG
Approval Date:Dec 12, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Dec 12, 2017TE:ABRLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
McKinsey
UBS
Merck
Harvard Business School
Citi
Farmers Insurance
Federal Trade Commission

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.