Orange Book product · Brand (NDA)
OSMITROL 20% IN WATER
MANNITOL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MANNITOL
Strength
20GM/100ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
NDA 013684
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- 2020BRONCHITOLBrand (NDA)
NDA 202049 · PHARMAXIS EUROPE
- 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
- —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.
