FDA Orange Book · active-ingredient family
Colchicine; probenecid
Colchicine; probenecid is approved as 1 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COLBENEMID · NDA 012383
1
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COLBENEMIDRLD | MERCK | NDA 012383 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PROBENECID AND COLCHICINE | RISING | ANDA 217030 | AB | Oct 24, 2023 | |
| PROBENECID AND COLCHICINE | INGENUS PHARMS LLC | ANDA 040618 | AB | May 13, 2008 | |
| COL-PROBENECIDRLD | WATSON LABS | ANDA 084279 | AB | Approved Prior to Jan 1, 1982 | |
| PROBEN-C | WATSON LABS | ANDA 085552 | — | Approved Prior to Jan 1, 1982 | |
| PROBENECID AND COLCHICINE | ANI PHARMS | ANDA 083734 | — | Approved Prior to Jan 1, 1982 | |
| PROBENECID AND COLCHICINE | BEECHAM | ANDA 084321 | — | Approved Prior to Jan 1, 1982 | |
| PROBENECID AND COLCHICINE | IMPAX LABS | ANDA 083720 | — | Approved Prior to Jan 1, 1982 | |
| PROBENECID AND COLCHICINE | SANDOZ | ANDA 086130 | — | Approved Prior to Jan 1, 1982 | |
| PROBENECID W/ COLCHICINE | LEDERLE | ANDA 086954 | — | Approved Prior to Jan 1, 1982 | |
| PROBENECID W/ COLCHICINE | WATSON LABS | ANDA 083221 | — | 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.
Colchicine; probenecid — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
