Orange Book product · Brand (NDA)
BRONCHITOL
MANNITOL
At a glance
Oct 30, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 30, 2020
5 yr 9 mo ago
Today
Exclusivity ends · ODE-327
Orphan-drug exclusivity (7 years)
Oct 30, 2027
in 1 yr 5 mo
Pharmaceutical detail
Active ingredient
MANNITOL
Strength
40MG
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 202049
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2010ARIDOL KITBrand (NDA)
NDA 022368 · PHARMAXIS EUROPE
- 1993MANNITOL 10% IN PLASTIC CONTAINERBrand (NDA)
NDA 020006 · B BRAUN
- 1987MANNITOL 10% IN PLASTIC CONTAINERBrand (NDA)
NDA 019603 · OTSUKA ICU MEDCL
- —MANNITOL 10%Brand (NDA)
NDA 016080 · B BRAUN
- —MANNITOL 10%Brand (NDA)
NDA 016269 · HOSPIRA
- —MANNITOL 10%Brand (NDA)
NDA 016472 · MILES
- —MANNITOL 20%Brand (NDA)
NDA 014738 · B BRAUN
- —MANNITOL 25%Brand (NDA)
NDA 005620 · MERCK
- —OSMITROL 10% IN WATERBrand (NDA)
NDA 013684 · BAXTER HLTHCARE
- —RESECTISOLBrand (NDA)
NDA 016704 · B BRAUN
- —RESECTISOL IN PLASTIC CONTAINERBrand (NDA)
NDA 016772 · B BRAUN
- 1987MANNITOL 25%Generic (ANDA)
ANDA 089239 · IGI LABS INC
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.
