FDA Orange Book · active-ingredient family
Sorbitol
Sorbitol is approved in 3 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SORBITOL 3% IN PLASTIC CONTAINER · NDA 018512
3
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SORBITOL 3% IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 018512 | — | May 27, 1982 | |
| SORBITOL 3% IN PLASTIC CONTAINER | BAXTER HLTHCARE | NDA 017863 | — | Approved Prior to Jan 1, 1982 | |
| SORBITOL 3.3% IN PLASTIC CONTAINER | B BRAUN | NDA 016741 | — | 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.
Sorbitol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
