FDA Orange Book · active-ingredient family
Chlorothiazide
Chlorothiazide is approved as 2 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:DIURIL · NDA 011870
2
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · suspension, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIURILRLD | SALIX PHARMS | NDA 011870 | — | Approved Prior to Jan 1, 1982 | |
| DIURILRLD×2 | RISING | NDA 011145 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CHLOROTHIAZIDE | WATSON LABS | ANDA 086795 | — | Aug 15, 1983 | |
| CHLOROTHIAZIDE | WATSON LABS | ANDA 086796 | — | Aug 15, 1983 | |
| CHLOROTHIAZIDE | WATSON LABS | ANDA 084026 | — | Sep 01, 1982 | |
| CHLOROTHIAZIDE | HIKMA INTL PHARMS | ANDA 086028 | — | Jul 14, 1982 | |
| CHLOROTHIAZIDE | HIKMA INTL PHARMS | ANDA 087736 | — | Jul 14, 1982 | |
| CHLOROTHIAZIDE | ABC HOLDING | ANDA 085569 | — | Approved Prior to Jan 1, 1982 | |
| CHLOROTHIAZIDE | LEDERLE | ANDA 086940 | — | Approved Prior to Jan 1, 1982 | |
| CHLOROTHIAZIDE | LEDERLE | ANDA 086938 | — | Approved Prior to Jan 1, 1982 | |
| CHLOROTHIAZIDE×2 | PHARMOBEDIENT | ANDA 084217 | — | Approved Prior to Jan 1, 1982 | |
| CHLOROTHIAZIDE | SANDOZ | ANDA 085485 | — | Approved Prior to Jan 1, 1982 | |
| CHLOROTHIAZIDE | WATSON LABS | ANDA 085165 | — | Approved Prior to Jan 1, 1982 | |
| CHLOROTHIAZIDE | WATSON LABS | ANDA 085173 | — | 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.
Chlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
