Orange Book product · Brand (NDA)
SORBITOL-MANNITOL IN PLASTIC CONTAINER
MANNITOL; SORBITOL
Brand (NDA)NDA 018316RX OTSUKA ICU MEDCL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
MANNITOL; SORBITOL
Strength
540MG/100ML;2.7GM/100ML
Dosage form
SOLUTION
Route
IRRIGATION
TE code
Not listed
Application
NDA 018316
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.
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.
