FDA Orange Book · active-ingredient family
Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride
Bisacodyl; polyethylene glycol 3350; potassium chloride; sodium bicarbonate; sodium chloride 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:HALFLYTELY · NDA 021551
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution, tablet, delayed release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HALFLYTELYRLD | BRAINTREE | NDA 021551 | — | Jul 16, 2010 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL | NOVEL LABS INC | ANDA 202217 | — | Aug 20, 2014 |
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.
Bisacodyl; 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.
