FDA Orange Book · active-ingredient family
Dextrose
Dextrose is approved as 27 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DEXTROSE 25% · NDA 019445
27
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXTROSE 25%RLD×2 | HOSPIRA | NDA 019445 | — | Nov 23, 1998 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD×2 | BAXTER HLTHCARE | NDA 020179 | AP | Dec 07, 1992 | |
| DEXTROSE 50% IN PLASTIC CONTAINERRLD×3 | BAXTER HLTHCARE | NDA 020047 | AP | Jul 02, 1991 | |
| DEXTROSE 70% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 019893 | AP | Dec 26, 1989 | |
| DEXTROSE 10% IN PLASTIC CONTAINERRLD×5 | B BRAUN | NDA 019626 | AP | Feb 02, 1988 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 019479 | AP | Sep 17, 1985 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD | HOSPIRA | NDA 019466 | AP | Jul 15, 1985 | |
| DEXTROSE 30% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 019345 | — | Jan 26, 1985 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD | ICU MEDICAL INC | NDA 019222 | — | Jul 13, 1984 | |
| DEXTROSE 20% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 018564 | — | Mar 23, 1982 | |
| DEXTROSE 40% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 018562 | — | Mar 23, 1982 | |
| DEXTROSE 50% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 018563 | AP | Mar 23, 1982 | |
| DEXTROSE 70% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 018561 | AP | Mar 23, 1982 | |
| DEXTROSE 10% IN PLASTIC CONTAINERRLD | BAXTER HLTHCARE | NDA 016694 | AP | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 10% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 018080 | AP | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 20% IN PLASTIC CONTAINERRLD×6 | BAXTER HLTHCARE | NDA 017521 | — | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD×2 | B BRAUN | NDA 016730 | AP | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD×2 | BAXTER HLTHCARE | NDA 016673 | AP | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 5% IN PLASTIC CONTAINERRLD | OTSUKA ICU MEDCL | NDA 016367 | AP | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 5% IN PLASTIC CONTAINER | DHL | NDA 019971 | — | Sep 28, 1995 | |
| DEXTROSE 50% IN PLASTIC CONTAINER | ICU MEDICAL INC | NDA 019894 | — | Dec 26, 1989 | |
| DEXTROSE 60% IN PLASTIC CONTAINER | HOSPIRA | NDA 019346 | — | Jan 25, 1985 | |
| DEXTROSE 38.5% IN PLASTIC CONTAINER | ABBOTT | NDA 018923 | — | Sep 19, 1984 | |
| DEXTROSE 60%×2 | B BRAUN | NDA 017995 | — | Sep 22, 1982 | |
| DEXTROSE 10% IN PLASTIC CONTAINER | B BRAUN | NDA 018046 | — | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 10% IN PLASTIC CONTAINER | MILES | NDA 018504 | — | Approved Prior to Jan 1, 1982 | |
| DEXTROSE 2.5% IN PLASTIC CONTAINER | B BRAUN | NDA 018358 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEXTROSE 5% | AM REGENT | ANDA 217263 | — | Apr 08, 2024 | |
| DEXTROSE 50% | INTL MEDICATION SYS | ANDA 203451 | AP | Mar 26, 2021 | |
| DEXTROSE 10% IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 209448 | AP | Jul 16, 2018 | |
| DEXTROSE 5% IN PLASTIC CONTAINER | FRESENIUS KABI USA | ANDA 207449 | AP | Oct 21, 2016 |
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.
Dextrose — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
