FDA Orange Book · active-ingredient family
Sodium nitroprusside
Sodium nitroprusside is approved as 4 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NIPRIDE RTU IN SODIUM CHLORIDE 0.9% · NDA 209387
4
Brand (NDA)
25
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIPRIDE RTU IN SODIUM CHLORIDE 0.9%RLD×3 | EXELA PHARMA | NDA 209387 | — | Dec 07, 2017 | |
| SODIUM NITROPRUSSIDERLD | BAXTER HLTHCARE | NDA 018581 | — | Jul 28, 1982 | |
| NITROPRESSRLD | ABBVIE | NDA 018450 | — | Approved Prior to Jan 1, 1982 | |
| NIPRIDE | ROCHE | NDA 017546 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SODIUM NITROPRUSSIDE | AVET LIFESCIENCES | ANDA 208923 | — | Nov 08, 2022 | |
| SODIUM NITROPRUSSIDE×3 | SLATE RUN PHARMA | ANDA 215846 | — | Aug 26, 2022 | |
| SODIUM NITROPRUSSIDE | BE PHARMS | ANDA 214971 | AP | Jul 12, 2021 | |
| SODIUM NITROPRUSSIDE | EUGIA PHARMA | ANDA 211934 | — | Dec 10, 2020 | |
| SODIUM NITROPRUSSIDE | XIROMED | ANDA 211277 | — | Oct 29, 2020 | |
| SODIUM NITROPRUSSIDE | SLATE RUN PHARMA | ANDA 214199 | AP | Aug 25, 2020 | |
| SODIUM NITROPRUSSIDE | CAPLIN | ANDA 211016 | AP | Nov 29, 2019 | |
| SODIUM NITROPRUSSIDE | DR REDDYS | ANDA 210114 | AP | Apr 10, 2019 | |
| SODIUM NITROPRUSSIDE | SUN PHARM | ANDA 210467 | — | Nov 26, 2018 | |
| SODIUM NITROPRUSSIDE | SOMERSET THERAPS LLC | ANDA 210882 | AP | Aug 17, 2018 | |
| SODIUM NITROPRUSSIDE | PHARMOBEDIENT | ANDA 209584 | AP | Aug 10, 2018 | |
| SODIUM NITROPRUSSIDE | CIPLA | ANDA 210855 | — | Jul 16, 2018 | |
| SODIUM NITROPRUSSIDE | CHARTWELL RX | ANDA 209834 | — | Jun 26, 2018 | |
| SODIUM NITROPRUSSIDE | MYLAN LABS LTD | ANDA 210763 | AP | Apr 17, 2018 | |
| SODIUM NITROPRUSSIDE | AMPHASTAR PHARMS INC | ANDA 209832 | — | Dec 18, 2017 | |
| SODIUM NITROPRUSSIDE | MICRO LABS | ANDA 209352 | AP | Dec 08, 2017 | |
| SODIUM NITROPRUSSIDE | AMNEAL | ANDA 209493 | AP | Nov 07, 2017 | |
| SODIUM NITROPRUSSIDE | NEXUS | ANDA 207499 | AP | May 25, 2017 | |
| SODIUM NITROPRUSSIDE | EPIC PHARMA LLC | ANDA 208635 | — | May 04, 2017 | |
| SODIUM NITROPRUSSIDE | SAGENT PHARMS INC | ANDA 207426 | AP | Dec 08, 2016 | |
| SODIUM NITROPRUSSIDE | TEVA PARENTERAL | ANDA 073465 | — | Mar 30, 1992 | |
| NITROPRESS | VPNA | ANDA 071961 | — | Aug 01, 1988 | |
| NITROPRESS | ABBOTT | ANDA 071555 | — | Nov 16, 1987 | |
| NITROPRESS | HOSPIRA | ANDA 070566 | — | Jun 09, 1986 | |
| SODIUM NITROPRUSSIDE | ABRAXIS PHARM | ANDA 070031 | — | Jan 17, 1985 |
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.
Sodium nitroprusside — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
