You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: January 30, 2026

Details for New Drug Application (NDA): 217357


✉ Email this page to a colleague

« Back to Dashboard


NDA 217357 describes NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), which is a drug marketed by Alvogen, Amneal Pharms, Aurobindo Pharma, Chartwell Rx, Inventia, Mankind Pharma, Micro Labs, Ranbaxy Labs Ltd, Sandoz, Sunny, and Watson Labs Inc, and is included in eleven NDAs. It is available from twenty-seven suppliers. Additional details are available on the NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) profile page.

The generic ingredient in NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) is nitrofurantoin; nitrofurantoin, macrocrystalline. There are twenty drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the nitrofurantoin; nitrofurantoin, macrocrystalline profile page.
Summary for 217357
Tradename:NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
Applicant:Mankind Pharma
Ingredient:nitrofurantoin; nitrofurantoin, macrocrystalline
Patents:0
Pharmacology for NDA: 217357
Suppliers and Packaging for NDA: 217357
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217357 ANDA BluePoint Laboratories 68001-606 68001-606-00 100 CAPSULE in 1 BOTTLE (68001-606-00)
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) nitrofurantoin; nitrofurantoin, macrocrystalline CAPSULE;ORAL 217357 ANDA NuCare Pharmaceuticals,Inc. 68071-3569 68071-3569-2 20 CAPSULE in 1 BOTTLE (68071-3569-2)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength75MG;25MG
Approval Date:Jul 11, 2023TE:ABRLD:No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.

 
© Copyright 2002-2026 thinkBiotech LLC
ISSN: 2162-2639
Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
LOE / Major Patent Expirations 2026 - 2027
 NCE-1 Patent Challenge Dates 2026 - 2027
Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
   See Primary Research Papers Citing DrugPatentWatch

Links