FDA — authorised 6 February 1953
- Status: approved
🇺🇸 Furadantin in United States
FDA authorised Furadantin on 6 February 1953
Marketing authorisations
FDA — authorised 6 February 1953
- Application: NDA008693
- Marketing authorisation holder: PROCTER AND GAMBLE
- Local brand name: FURADANTIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 December 1953
- Application: NDA009175
- Marketing authorisation holder: CASPER PHARMA LLC
- Local brand name: FURADANTIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 September 1970
- Application: ANDA080017
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: FURALAN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 November 1970
- Application: ANDA080043
- Marketing authorisation holder: SANDOZ
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 November 1978
- Application: ANDA085796
- Marketing authorisation holder: WATSON LABS
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 1978
- Application: ANDA085797
- Marketing authorisation holder: WATSON LABS
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 July 1984
- Application: ANDA084326
- Marketing authorisation holder: WATSON LABS
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 April 1987
- Application: ANDA080447
- Marketing authorisation holder: WATSON LABS
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 May 1988
- Application: NDA016620
- Marketing authorisation holder: ALMATICA
- Indication: Labeling
- Status: approved
FDA — authorised 31 December 1992
- Application: ANDA073696
- Marketing authorisation holder: WATSON LABS
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 1993
- Application: ANDA073652
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 January 1993
- Application: ANDA073671
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 January 1995
- Application: ANDA074336
- Marketing authorisation holder: POM PHARMA
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 9 July 1997
- Application: ANDA074967
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 March 2004
- Application: ANDA076648
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 August 2004
- Application: ANDA077025
- Marketing authorisation holder: AUROBINDO PHARMA USA
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 March 2005
- Application: ANDA076951
- Marketing authorisation holder: RANBAXY LABS LTD
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 April 2005
- Application: ANDA077066
- Marketing authorisation holder: SANDOZ
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 June 2007
- Application: NDA020064
- Marketing authorisation holder: ALMATICA
- Indication: Labeling
- Status: approved
FDA — authorised 11 May 2011
- Application: ANDA201679
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 August 2013
- Application: ANDA201355
- Marketing authorisation holder: STRIDES PHARMA
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 8 September 2014
- Application: ANDA201693
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 18 June 2015
- Application: ANDA091095
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 July 2015
- Application: ANDA202250
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 February 2016
- Application: ANDA201722
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 May 2016
- Application: ANDA205180
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 July 2018
- Application: ANDA203233
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 June 2021
- Application: ANDA211935
- Marketing authorisation holder: ALEMBIC
- Status: approved
FDA — authorised 18 February 2022
- Application: ANDA211013
- Marketing authorisation holder: INVENTIA
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 July 2022
- Application: ANDA215002
- Marketing authorisation holder: ALVOGEN
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 March 2023
- Application: ANDA217272
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: NITROFURANTOIN
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 May 2023
- Application: ANDA212607
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 11 July 2023
- Application: ANDA217357
- Marketing authorisation holder: MANKIND PHARMA
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 November 2023
- Application: ANDA217073
- Marketing authorisation holder: OMSAV PHARMA
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 October 2024
- Application: ANDA218346
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 14 January 2025
- Application: ANDA208909
- Marketing authorisation holder: SOMERSET THERAPS LLC
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 2 July 2025
- Application: ANDA219495
- Marketing authorisation holder: ANNORA PHARMA
- Local brand name: NITROFURANTOIN
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 7 April 2026
- Application: ANDA220269
- Marketing authorisation holder: CREEKWOOD PHARMS
- Local brand name: NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
- Indication: CAPSULE — ORAL
- Status: approved
The FDA approved Furadantin (nitrofurantoin monohydrate/macrocystals) capsules for oral use on 7 April 2026. This approval was granted to Creekwood Pharms under the standard expedited pathway. The approved indication is for the treatment of urinary tract infections.
FDA
- Application: ANDA080003
- Marketing authorisation holder: ELKINS SINN
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA084085
- Marketing authorisation holder: WHITEWORTH TOWN PLSN
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA080078
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: NITROFURANTOIN
- Indication: TABLET — ORAL
- Status: approved
Furadantin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Furadantin approved in United States?
Yes. FDA authorised it on 6 February 1953; FDA authorised it on 6 February 1953; FDA authorised it on 23 December 1953.
Who is the marketing authorisation holder for Furadantin in United States?
Marketing authorisation holder not available in our data.