Orange Book product · Brand (NDA)
ARIDOL KIT
MANNITOL
At a glance
Oct 05, 2010
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 05, 2010
15 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
MANNITOL
Strength
N/A,5MG,10MG,20MG,40MG
Dosage form
POWDER
Route
INHALATION
TE code
Not listed
Application
NDA 022368
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.
- 2020BRONCHITOLBrand (NDA)
NDA 202049 · 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
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.
