Orange Book product · Brand (NDA)
NULYTELY
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
At a glance
Apr 22, 1991
Approved
Brand (NDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 22, 1991
35 yr 8 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
NDA 019797
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.
- 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
- 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.
