Orange Book product · Generic (ANDA)
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
At a glance
Jul 09, 2009
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 09, 2009
17 yr 2 mo ago
Today
Pharmaceutical detail
Active ingredient
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
Strength
10MG;12.5MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 090228
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
- 1994MONOPRIL-HCTBrand (NDA)
NDA 020286 · BRISTOL MYERS SQUIBB
- 2010FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079025 · CHARTWELL RX
- 2009FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDEGeneric (ANDA)
ANDA 079245 · AUROBINDO PHARMA
- 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.
