FDA Orange Book · active-ingredient family
Amiloride hydrochloride; hydrochlorothiazide
Amiloride hydrochloride; hydrochlorothiazide is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MODURETIC 5-50 · NDA 018201
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MODURETIC 5-50RLD | MERCK | NDA 018201 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | CHARTWELL RX | ANDA 073357 | — | Nov 27, 1991 | |
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | RISING | ANDA 073209 | AB | Oct 31, 1991 | |
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 073334 | — | Jul 19, 1991 | |
| HYDRO-RIDE | PAR PHARM | ANDA 070347 | — | Dec 25, 1990 | |
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | BARR | ANDA 071111 | AB | May 10, 1988 | |
| AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE | TEVA | ANDA 070795 | — | Apr 17, 1988 |
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.
Amiloride hydrochloride; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
