FDA Orange Book · active-ingredient family
Hydrochlorothiazide; spironolactone
Hydrochlorothiazide; spironolactone is approved as 1 brand and 17 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:ALDACTAZIDE · NDA 012616
1
Brand (NDA)
17
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALDACTAZIDERLD×2 | PFIZER | NDA 012616 | AB | Dec 30, 1982 |
Generic (ANDA) products (17)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | SUN PHARM INDUSTRIES | ANDA 089534 | AB | Jul 02, 1987 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | PUREPAC PHARM | ANDA 087999 | — | Nov 06, 1985 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | SUPERPHARM | ANDA 089137 | — | Aug 26, 1985 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | ASCOT | ANDA 088025 | — | Nov 23, 1984 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | PUREPAC PHARM | ANDA 088054 | — | Aug 18, 1983 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | PARKE DAVIS | ANDA 087948 | — | Feb 22, 1983 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | IVAX PHARMS | ANDA 087004 | — | May 24, 1982 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | CHARTWELL RX | ANDA 086881 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | MUTUAL PHARM | ANDA 087267 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | MYLAN | ANDA 086513 | AB | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 087398 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | LEDERLE | ANDA 087511 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | UPSHER SMITH | ANDA 087553 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | USL PHARMA | ANDA 087651 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | VANGARD | ANDA 087655 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 085974 | — | Approved Prior to Jan 1, 1982 | |
| SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE | WATSON LABS | ANDA 086026 | — | 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; spironolactone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
