Orange Book product · Brand (NDA)
MACRODANTIN
NITROFURANTOIN, MACROCRYSTALLINE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
NITROFURANTOIN, MACROCRYSTALLINE
Strength
25MG
Dosage form
CAPSULE
Route
ORAL
TE code
AB
Application
NDA 016620
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024NITROFURANTOINGeneric (ANDA)
ANDA 077025 · AUROBINDO PHARMA USA
- 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.
