Orange Book product · Generic (ANDA)
NITROFURANTOIN
NITROFURANTOIN, MACROCRYSTALLINE
At a glance
Oct 02, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 02, 2024
1 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
ANDA 077025
Product number
002
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of NITROFURANTOIN, MACROCRYSTALLINE
- —MACRODANTINBrand (NDA)
NDA 016620 · ALMATICA
- 2023NITROFURANTOINGeneric (ANDA)
ANDA 217272 · MANKIND PHARMA
- 2021NITROFURANTOINGeneric (ANDA)
ANDA 211935 · ALEMBIC
- 2018NITROFURANTOINGeneric (ANDA)
ANDA 203233 · NOVEL LABS INC
- 2017NITROFURANTOINGeneric (ANDA)
ANDA 205005 · ZYDUS PHARMS
- 2016NITROFURANTOINGeneric (ANDA)
ANDA 201722 · SUN PHARM INDUSTRIES
- 2015NITROFURANTOINGeneric (ANDA)
ANDA 091095 · ACTAVIS LABS FL INC
- 1997NITROFURANTOINGeneric (ANDA)
ANDA 074967 · AUROBINDO PHARMA USA
- 1995NITROFURANTOINGeneric (ANDA)
ANDA 074336 · POM PHARMA
- 1993NITROFURANTOINGeneric (ANDA)
ANDA 073671 · IMPAX LABS INC
- 1993NITROFURANTOINGeneric (ANDA)
ANDA 073652 · IMPAX LABS INC
- 1992NITROFURANTOINGeneric (ANDA)
ANDA 073696 · WATSON LABS
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.
