Orange Book product · Generic (ANDA)
NITROFURANTOIN
NITROFURANTOIN
At a glance
Apr 14, 2023
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 14, 2023
3 yr 3 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROFURANTOIN
Strength
25MG/5ML
Dosage form
SUSPENSION
Route
ORAL
TE code
AB
Application
ANDA 216385
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NITROFURANTOIN
- —FURADANTINBrand (NDA)
NDA 009175 · CASPER PHARMA LLC
- —FURADANTINBrand (NDA)
NDA 008693 · PROCTER AND GAMBLE
- 2025NITROFURANTOINGeneric (ANDA)
ANDA 219495 · ANNORA PHARMA
- 2025NITROFURANTOINGeneric (ANDA)
ANDA 208909 · SOMERSET THERAPS LLC
- 2024NITROFURANTOINGeneric (ANDA)
ANDA 218346 · BIOCON PHARMA
- 2023NITROFURANTOINGeneric (ANDA)
ANDA 212607 · AUROBINDO PHARMA
- 2016NITROFURANTOINGeneric (ANDA)
ANDA 205180 · ACTAVIS MID ATLANTIC
- 2014NITROFURANTOINGeneric (ANDA)
ANDA 201693 · NOVEL LABS INC
- 2013NITROFURANTOINGeneric (ANDA)
ANDA 201355 · STRIDES PHARMA
- 2011NITROFURANTOINGeneric (ANDA)
ANDA 201679 · AMNEAL PHARMS
- —NITROFURANTOINGeneric (ANDA)
ANDA 084326 · WATSON LABS
- —FURALANGeneric (ANDA)
ANDA 080017 · CHARTWELL MOLECULAR
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
