FDA Orange Book · active-ingredient family
Potassium aminosalicylate
Potassium aminosalicylate 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:PASKALIUM · NDA 009395
1
Brand (NDA)
1
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, powder, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PASKALIUM×2 | GLENWOOD | NDA 009395 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| POTASSIUM AMINOSALICYLATE | HEXCEL | ANDA 080098 | — | Approved Prior to Jan 1, 1982 |
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.
Potassium aminosalicylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
