FDA Orange Book · active-ingredient family
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate
Polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride; sodium sulfate is approved as 1 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:OCL · NDA 019284
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| OCL | HOSPIRA | NDA 019284 | — | Apr 30, 1986 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLENZ-LYTE | PADDOCK LLC | ANDA 090769 | — | Jun 07, 2010 |
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; sodium sulfate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
