Orange Book product · Generic (ANDA)
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Strength
25MG;25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 086513
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
- 1982ALDACTAZIDEBrand (NDA)
NDA 012616 · PFIZER
- 1987SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 089534 · SUN PHARM INDUSTRIES
- 1985SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087999 · PUREPAC PHARM
- 1985SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 089137 · SUPERPHARM
- 1984SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 088025 · ASCOT
- 1983SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 088054 · PUREPAC PHARM
- 1983SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087948 · PARKE DAVIS
- 1982SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087004 · IVAX PHARMS
- —SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 086881 · CHARTWELL RX
- —SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087267 · MUTUAL PHARM
- —SPIRONOLACTONE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087398 · WATSON LABS
- —SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 087511 · LEDERLE
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.
