FDA Orange Book · active-ingredient family
Isoflurane
Isoflurane is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:FORANE · NDA 017624
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · liquid
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FORANERLD | BAXTER HLTHCARE | NDA 017624 | AN | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ISOFLURANE | SHANDONG | ANDA 216527 | AN | Nov 04, 2025 | |
| ISOFLURANE | HALOCARBON PRODS | ANDA 075225 | AN | Oct 20, 1999 | |
| ISOFLURANE | PIRAMAL PHARMA | ANDA 074502 | AN | Jun 27, 1995 | |
| ISOFLURANE | WATSON LABS INC | ANDA 074393 | — | May 12, 1995 | |
| ISOFLURANE | PIRAMAL CRITICAL | ANDA 074416 | AN | Sep 30, 1994 | |
| ISOFLURANE | HOSPIRA | ANDA 074097 | — | Jan 25, 1993 |
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.
Isoflurane — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
