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 02, 2010
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 2010
16 yr 5 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
Not listed
Application
ANDA 090409
Product number
001
Marketing status
DISCN
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
- 2015PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDEGeneric (ANDA)
ANDA 204559 · STRIDES PHARMA
- 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.
