FDA Orange Book · active-ingredient family
Hydrochlorothiazide; reserpine
Hydrochlorothiazide; reserpine is approved as 2 brand and 21 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:HYDROPRES 25 · NDA 011958
2
Brand (NDA)
21
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| HYDROPRES 25×2 | MERCK | NDA 011958 | — | Approved Prior to Jan 1, 1982 | |
| SERPASIL-ESIDRIX #1×2 | NOVARTIS | NDA 011878 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (21)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RESERPINE AND HYDROCHLOROTHIAZIDE-50 | WEST WARD | ANDA 088189 | — | May 10, 1984 | |
| RESERPINE AND HYDROCHLOROTHIAZIDE | SANDOZ | ANDA 088200 | — | Jan 31, 1984 | |
| HYDRO-RESERP | ABC HOLDING | ANDA 084714 | — | Jun 29, 1982 | |
| H.R.-50 | WHITEWORTH TOWN PLSN | ANDA 085338 | — | Approved Prior to Jan 1, 1982 | |
| "HYDRO-SERP ""25""" | SANDOZ | ANDA 084827 | — | Approved Prior to Jan 1, 1982 | |
| "HYDRO-SERP ""50""" | SANDOZ | ANDA 085213 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | IVAX SUB TEVA PHARMS | ANDA 083572 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | IVAX SUB TEVA PHARMS | ANDA 083571 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | IVAX SUB TEVA PHARMS | ANDA 083568 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | IVAX SUB TEVA PHARMS | ANDA 083573 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | PHARMERAL | ANDA 085421 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | PHARMERAL | ANDA 085420 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | ROXANE | ANDA 084603 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 084466 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 085317 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 086330 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 083666 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 084467 | — | Approved Prior to Jan 1, 1982 | |
| HYDROCHLOROTHIAZIDE W/ RESERPINE | WATSON LABS | ANDA 086331 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE AND HYDROCHLOROTHIAZIDE | BARR | ANDA 084580 | — | Approved Prior to Jan 1, 1982 | |
| RESERPINE AND HYDROCHLOROTHIAZIDE | BARR | ANDA 084579 | — | 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.
Hydrochlorothiazide; reserpine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
