FDA Orange Book · active-ingredient family
Fosinopril sodium; hydrochlorothiazide
Fosinopril sodium; hydrochlorothiazide is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MONOPRIL-HCT · NDA 020286
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MONOPRIL-HCTRLD×2 | BRISTOL MYERS SQUIBB | NDA 020286 | — | Nov 30, 1994 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | CHARTWELL RX | ANDA 079025 | — | Sep 17, 2010 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | AUROBINDO PHARMA | ANDA 079245 | AB | Jul 09, 2009 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | INVAGEN PHARMS | ANDA 090228 | AB | Jul 09, 2009 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | MYLAN | ANDA 077705 | — | Aug 14, 2006 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | TEVA | ANDA 076945 | — | Jul 05, 2006 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | SANDOZ | ANDA 076961 | AB | Sep 28, 2005 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | ANI PHARMS | ANDA 077144 | — | Aug 16, 2005 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | SUN PHARM INDS LTD | ANDA 076739 | — | Dec 17, 2004 | |
| FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE×2 | ANI PHARMS | ANDA 076608 | — | Dec 03, 2004 |
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.
Fosinopril sodium; hydrochlorothiazide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
