FDA Orange Book · active-ingredient family
Captopril; hydrochlorothiazide
Captopril; hydrochlorothiazide is approved as 1 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CAPOZIDE 25/15 · NDA 018709
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAPOZIDE 25/15RLD×4 | APOTHECON | NDA 018709 | — | Oct 12, 1984 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE×4 | IVAX SUB TEVA PHARMS | ANDA 075055 | — | Jun 18, 1998 | |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE×4 | COSETTE PHARMS NC | ANDA 074827 | — | Dec 29, 1997 | |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE×4 | RISING | ANDA 074896 | — | Dec 29, 1997 | |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE×4 | STRIDES PHARMA INTL | ANDA 074788 | — | Dec 29, 1997 | |
| CAPTOPRIL AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 074832 | — | Dec 29, 1997 |
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.
Captopril; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
