FDA Orange Book · active-ingredient family
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NULYTELY · NDA 019797
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NULYTELYRLD×2 | AZURITY | NDA 019797 | AA | Apr 22, 1991 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | SOLIS PHARMS | ANDA 202060 | — | Mar 08, 2017 | |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | STRIDES PHARMA | ANDA 204559 | AA | Apr 13, 2015 | |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | EXTROVIS | ANDA 090409 | — | Apr 02, 2010 | |
| LAX-LYTE WITH FLAVOR PACKS | L PERRIGO CO | ANDA 079232 | — | Feb 25, 2010 | |
| PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE | NOVEL LABS INC | ANDA 090019 | AA | May 27, 2009 | |
| TRILYTE | AUROBINDO PHARMA USA | ANDA 076491 | AA | Feb 05, 2004 |
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.
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
