FDA Orange Book · active-ingredient family
Nitrofurantoin, macrocrystalline
Nitrofurantoin, macrocrystalline is approved as 1 brand and 14 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MACRODANTIN · NDA 016620
1
Brand (NDA)
14
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MACRODANTINRLD×3 | ALMATICA | NDA 016620 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (14)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NITROFURANTOIN×2 | AUROBINDO PHARMA USA | ANDA 077025 | AB | Oct 02, 2024 | |
| NITROFURANTOIN×3 | MANKIND PHARMA | ANDA 217272 | AB | Mar 21, 2023 | |
| NITROFURANTOIN×3 | ALEMBIC | ANDA 211935 | AB | Jun 25, 2021 | |
| NITROFURANTOIN×2 | NOVEL LABS INC | ANDA 203233 | AB | Jul 09, 2018 | |
| NITROFURANTOIN×2 | ZYDUS PHARMS | ANDA 205005 | AB | Dec 12, 2017 | |
| NITROFURANTOIN×3 | SUN PHARM INDUSTRIES | ANDA 201722 | — | Feb 16, 2016 | |
| NITROFURANTOIN×3 | ACTAVIS LABS FL INC | ANDA 091095 | — | Jun 18, 2015 | |
| NITROFURANTOIN×2 | AUROBINDO PHARMA USA | ANDA 074967 | AB | Jul 09, 1997 | |
| NITROFURANTOIN×3 | POM PHARMA | ANDA 074336 | — | Jan 25, 1995 | |
| NITROFURANTOIN | IMPAX LABS INC | ANDA 073671 | AB | Jan 28, 1993 | |
| NITROFURANTOIN | IMPAX LABS INC | ANDA 073652 | AB | Jan 28, 1993 | |
| NITROFURANTOIN×3 | WATSON LABS | ANDA 073696 | — | Dec 31, 1992 | |
| NITROFURANTOIN MACROCRYSTALLINE | WATSON LABS | ANDA 070248 | — | Jun 24, 1988 | |
| NITROFURANTOIN MACROCRYSTALLINE | WATSON LABS | ANDA 070249 | — | Jun 24, 1988 |
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.
Nitrofurantoin, macrocrystalline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
