Orange Book product · Brand (NDA)
MODURETIC 5-50
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
Strength
EQ 5MG ANHYDROUS;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 018201
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1991AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 073357 · CHARTWELL RX
- 1991AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 073209 · RISING
- 1991AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 073334 · WATSON LABS
- 1990HYDRO-RIDEGeneric (ANDA)
ANDA 070347 · PAR PHARM
- 1988AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 071111 · BARR
- 1988AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 070795 · TEVA
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.
