FDA Orange Book · active-ingredient family
Fosinopril sodium
Fosinopril sodium is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MONOPRIL · NDA 019915
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MONOPRILRLD×3 | BRISTOL MYERS SQUIBB | NDA 019915 | — | May 16, 1991 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOSINOPRIL SODIUM×3 | PRINSTON INC | ANDA 205670 | AB | Aug 29, 2016 | |
| FOSINOPRIL SODIUM×3 | AUROBINDO PHARMA LTD | ANDA 091163 | AB | Mar 30, 2011 | |
| FOSINOPRIL SODIUM×3 | WATSON LABS | ANDA 077531 | — | Aug 31, 2006 | |
| FOSINOPRIL SODIUM×3 | APOTEX | ANDA 076906 | — | May 17, 2005 | |
| FOSINOPRIL SODIUM×3 | INVAGEN PHARMS | ANDA 077222 | AB | Apr 20, 2005 | |
| FOSINOPRIL SODIUM×3 | WATSON LABS | ANDA 076987 | — | Dec 23, 2004 | |
| FOSINOPRIL SODIUM×3 | ACTAVIS LABS FL INC | ANDA 076620 | — | Oct 15, 2004 | |
| FOSINOPRIL SODIUM×3 | UPSHER SMITH LABS | ANDA 076188 | — | Oct 08, 2004 | |
| FOSINOPRIL SODIUM×3 | CHARTWELL RX | ANDA 076483 | AB | Apr 23, 2004 | |
| FOSINOPRIL SODIUM×3 | RANBAXY LABS LTD | ANDA 076580 | — | Apr 23, 2004 | |
| FOSINOPRIL SODIUM×3 | TEVA | ANDA 076139 | AB | Nov 25, 2003 |
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 — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
