FDA Orange Book · active-ingredient family
Hydroflumethiazide; reserpine
Hydroflumethiazide; reserpine 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:SALUTENSIN · NDA 012359
1
Brand (NDA)
5
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SALUTENSIN×2 | SHIRE | NDA 012359 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RESERPINE AND HYDROFLUMETHIAZIDE | PAR PHARM | ANDA 088907 | — | Sep 20, 1985 | |
| RESERPINE AND HYDROFLUMETHIAZIDE | IVAX PHARMS | ANDA 088932 | — | Jan 11, 1985 | |
| HYDROFLUMETHIAZIDE AND RESERPINE | USL PHARMA | ANDA 088195 | — | Oct 26, 1983 | |
| HYDROFLUMETHIAZIDE AND RESERPINE | WATSON LABS | ANDA 088127 | — | Mar 22, 1983 | |
| HYDROFLUMETHIAZIDE AND RESERPINE | WATSON LABS | ANDA 088110 | — | Mar 22, 1983 |
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.
Hydroflumethiazide; reserpine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

