Orange Book product · Brand (NDA)
MONOPRIL-HCT
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
At a glance
Nov 30, 1994
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 30, 1994
32 yr ago
Today
Pharmaceutical detail
Active ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Strength
10MG;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 020286
Product number
002
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.
- 2010FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079025 · CHARTWELL RX
- 2009FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079245 · AUROBINDO PHARMA
- 2009FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 090228 · INVAGEN PHARMS
- 2006FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 077705 · MYLAN
- 2006FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076945 · TEVA
- 2005FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076961 · SANDOZ
- 2005FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 077144 · ANI PHARMS
- 2004FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076739 · SUN PHARM INDS LTD
- 2004FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 076608 · ANI PHARMS
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.
