FDA Orange Book · active-ingredient family
Chlorthalidone; clonidine hydrochloride
Chlorthalidone; clonidine hydrochloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COMBIPRES · NDA 017503
1
Brand (NDA)
4
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COMBIPRESRLD×3 | BOEHRINGER INGELHEIM | NDA 017503 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE | PAR PHARM | ANDA 071179 | — | Dec 16, 1987 | |
| CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE | PAR PHARM | ANDA 071178 | — | Dec 16, 1987 | |
| CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE | PAR PHARM | ANDA 071142 | — | Dec 16, 1987 | |
| CLORPRES×3 | NATCO PHARMA | ANDA 071325 | — | Feb 09, 1987 |
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.
Chlorthalidone; clonidine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
