FDA Orange Book · active-ingredient family
Nitrofurantoin
Nitrofurantoin is approved as 2 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FURADANTIN · NDA 009175
2
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FURADANTINRLD×2 | CASPER PHARMA LLC | NDA 009175 | AB | Approved Prior to Jan 1, 1982 | |
| FURADANTIN×2 | PROCTER AND GAMBLE | NDA 008693 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NITROFURANTOIN | ANNORA PHARMA | ANDA 219495 | AB | Jul 02, 2025 | |
| NITROFURANTOIN | SOMERSET THERAPS LLC | ANDA 208909 | AB | Jan 14, 2025 | |
| NITROFURANTOIN | BIOCON PHARMA | ANDA 218346 | AB | Oct 28, 2024 | |
| NITROFURANTOIN | AUROBINDO PHARMA | ANDA 212607 | AB | May 11, 2023 | |
| NITROFURANTOIN | NOVITIUM PHARMA | ANDA 216385 | AB | Apr 14, 2023 | |
| NITROFURANTOIN | ACTAVIS MID ATLANTIC | ANDA 205180 | AB | May 03, 2016 | |
| NITROFURANTOIN | NOVEL LABS INC | ANDA 201693 | AB | Sep 08, 2014 | |
| NITROFURANTOIN | STRIDES PHARMA | ANDA 201355 | AB | Aug 14, 2013 | |
| NITROFURANTOIN | AMNEAL PHARMS | ANDA 201679 | — | May 11, 2011 | |
| NITROFURANTOIN×2 | WATSON LABS | ANDA 084326 | — | Approved Prior to Jan 1, 1982 | |
| FURALAN×2 | CHARTWELL MOLECULAR | ANDA 080017 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN×2 | ELKINS SINN | ANDA 080003 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN×2 | IVAX SUB TEVA PHARMS | ANDA 080078 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN×2 | SANDOZ | ANDA 080043 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN×2 | WATSON LABS | ANDA 080447 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN | WATSON LABS | ANDA 085797 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN | WATSON LABS | ANDA 085796 | — | Approved Prior to Jan 1, 1982 | |
| NITROFURANTOIN | WHITEWORTH TOWN PLSN | ANDA 084085 | — | Approved Prior to Jan 1, 1982 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
