FDA Orange Book · active-ingredient family
Mannitol
Mannitol is approved as 12 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BRONCHITOL · NDA 202049
12
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
1
Exclusivity periods
Brand (NDA) products · injectable, powder, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BRONCHITOLRLD | PHARMAXIS EUROPE | NDA 202049 | — | Oct 30, 2020 | |
| ARIDOL KITRLD | PHARMAXIS EUROPE | NDA 022368 | — | Oct 05, 2010 | |
| OSMITROL 20% IN WATER IN PLASTIC CONTAINERRLD×8 | BAXTER HLTHCARE | NDA 013684 | AP | Approved Prior to Jan 1, 1982 | |
| MANNITOL 10% IN PLASTIC CONTAINER×4 | B BRAUN | NDA 020006 | AP | Jul 26, 1993 | |
| MANNITOL 10% IN PLASTIC CONTAINER×4 | OTSUKA ICU MEDCL | NDA 019603 | — | Jan 08, 1987 | |
| MANNITOL 10%×7 | B BRAUN | NDA 016080 | — | Approved Prior to Jan 1, 1982 | |
| MANNITOL 10%×6 | HOSPIRA | NDA 016269 | — | Approved Prior to Jan 1, 1982 | |
| MANNITOL 10%×3 | MILES | NDA 016472 | — | Approved Prior to Jan 1, 1982 | |
| MANNITOL 20% | B BRAUN | NDA 014738 | — | Approved Prior to Jan 1, 1982 | |
| MANNITOL 25% | MERCK | NDA 005620 | — | Approved Prior to Jan 1, 1982 | |
| RESECTISOL | B BRAUN | NDA 016704 | — | Approved Prior to Jan 1, 1982 | |
| RESECTISOL IN PLASTIC CONTAINER | B BRAUN | NDA 016772 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MANNITOL 25% | IGI LABS INC | ANDA 089239 | — | May 06, 1987 | |
| MANNITOL 25% | IGI LABS INC | ANDA 089240 | — | May 06, 1987 | |
| MANNITOL 25% | WATSON LABS | ANDA 087460 | — | Jun 27, 1983 | |
| MANNITOL 25% | LUITPOLD | ANDA 087409 | — | Jan 21, 1982 | |
| MANNITOL 25% | ABRAXIS PHARM | ANDA 086754 | — | Approved Prior to Jan 1, 1982 | |
| MANNITOL 25% | FRESENIUS KABI USA | ANDA 080677 | AP | Approved Prior to Jan 1, 1982 | |
| MANNITOL 25% | INTL MEDICATION | ANDA 083051 | — | Approved Prior to Jan 1, 1982 |
Marketing exclusivity (1)
- ODE-327Orphan-drug exclusivity (7 years)
Oct 30, 2027
in 1 yr 5 mo
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.
Mannitol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
