Orange Book product · Generic (ANDA)
PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
At a glance
Apr 13, 2015
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 13, 2015
11 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Strength
420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 204559
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
- 1991NULYTELYBrand (NDA)
NDA 019797 · AZURITY
- 2017PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEGeneric (ANDA)
ANDA 202060 · SOLIS PHARMS
- 2010PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEGeneric (ANDA)
ANDA 090409 · EXTROVIS
- 2010LAX-LYTE WITH FLAVOR PACKSGeneric (ANDA)
ANDA 079232 · L PERRIGO CO
- 2009PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEGeneric (ANDA)
ANDA 090019 · NOVEL LABS INC
- 2004TRILYTEGeneric (ANDA)
ANDA 076491 · AUROBINDO PHARMA USA
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.
