FDA Orange Book · active-ingredient family
Nitrofurantoin; nitrofurantoin, macrocrystalline
Nitrofurantoin; nitrofurantoin, macrocrystalline is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MACROBID · NDA 020064
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MACROBIDRLD | ALMATICA | NDA 020064 | AB | Dec 24, 1991 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | CREEKWOOD PHARMS | ANDA 220269 | AB | Apr 07, 2026 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | OMSAV PHARMA | ANDA 217073 | AB | Nov 03, 2023 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | MANKIND PHARMA | ANDA 217357 | AB | Jul 11, 2023 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | AUROBINDO PHARMA | ANDA 209225 | AB | Mar 30, 2023 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | ALVOGEN | ANDA 215002 | — | Jul 20, 2022 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | INVENTIA | ANDA 211013 | AB | Feb 18, 2022 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | SUNNY | ANDA 208516 | AB | May 24, 2018 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | AMNEAL PHARMS | ANDA 207372 | — | May 15, 2017 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | WATSON LABS INC | ANDA 202250 | AB | Jul 08, 2015 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | SANDOZ | ANDA 077066 | AB | Apr 05, 2005 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | RANBAXY LABS LTD | ANDA 076951 | — | Mar 30, 2005 | |
| NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) | CHARTWELL RX | ANDA 076648 | — | Mar 22, 2004 |
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; nitrofurantoin, macrocrystalline — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
