FDA Orange Book · active-ingredient family
Flucytosine
Flucytosine is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ANCOBON · NDA 017001
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANCOBONRLD×2 | BAUSCH | NDA 017001 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FLUCYTOSINE×2 | LAURUS | ANDA 218005 | AB | Jul 23, 2025 | |
| FLUCYTOSINE×2 | AUROBINDO PHARMA LTD | ANDA 213665 | AB | May 01, 2020 | |
| FLUCYTOSINE×2 | STRIDES PHARMA | ANDA 212632 | AB | Apr 17, 2020 | |
| FLUCYTOSINE×2 | STRIDES PHARMA | ANDA 207536 | — | Jun 18, 2018 | |
| FLUCYTOSINE×2 | HIKMA | ANDA 206550 | — | Oct 17, 2017 | |
| FLUCYTOSINE×2 | NOVEL LABS INC | ANDA 204652 | AB | Jul 07, 2017 | |
| FLUCYTOSINE×2 | SIGMAPHARM LABS LLC | ANDA 201566 | AB | Jun 28, 2011 |
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.
Flucytosine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
