FDA Orange Book · active-ingredient family
Chlorothiazide; methyldopa
Chlorothiazide; methyldopa is approved as 1 brand and 2 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALDOCLOR-150 · NDA 016016
1
Brand (NDA)
2
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALDOCLOR-150×2 | MERCK | NDA 016016 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (2)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| METHYLDOPA AND CHLOROTHIAZIDE | PAR PHARM | ANDA 070783 | — | Nov 06, 1987 | |
| METHYLDOPA AND CHLOROTHIAZIDE | PAR PHARM | ANDA 070654 | — | Nov 06, 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.
Chlorothiazide; methyldopa — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

