FDA Orange Book · active-ingredient family
Cisatracurium besylate
Cisatracurium besylate is approved as 1 brand and 26 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NIMBEX · NDA 020551
1
Brand (NDA)
26
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIMBEXRLD×3 | ABBVIE | NDA 020551 | — | Dec 15, 1995 |
Generic (ANDA) products (26)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CISATRACURIUM BESYLATE PRESERVATIVE FREE×2 | HAINAN POLY | ANDA 216539 | AP | Aug 27, 2024 | |
| CISATRACURIUM BESYLATE | HAINAN POLY | ANDA 216538 | — | Mar 08, 2024 | |
| CISATRACURIUM BESYLATE×2 | CAPLIN | ANDA 217725 | AP | Jun 09, 2023 | |
| CISATRACURIUM BESYLATE | HIKMA | ANDA 203079 | AP | Apr 19, 2023 | |
| CISATRACURIUM BESYLATE×2 | HIKMA | ANDA 203078 | AP | Jun 28, 2022 | |
| CISATRACURIUM BESYLATE×3 | GLAND | ANDA 215516 | AP | May 24, 2022 | |
| CISATRACURIUM BESYLATE×2 | PIRAMAL | ANDA 212432 | AP | Mar 11, 2022 | |
| CISATRACURIUM BESYLATE×2 | SAGENT PHARMS INC | ANDA 201836 | AP | Nov 06, 2020 | |
| CISATRACURIUM BESYLATE | SAGENT PHARMS INC | ANDA 201851 | AP | Nov 06, 2020 | |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE | EUGIA PHARMA | ANDA 209665 | — | Oct 27, 2020 | |
| CISATRACURIUM BESYLATE | ZYDUS PHARMS | ANDA 213527 | — | Sep 01, 2020 | |
| CISATRACURIUM BESYLATE | EUGIA PHARMA | ANDA 209144 | — | May 08, 2020 | |
| CISATRACURIUM BESYLATE×2 | ZYDUS PHARMS | ANDA 212171 | AP | Nov 04, 2019 | |
| CISATRACURIUM BESYLATE×2 | MEITHEAL | ANDA 211668 | AP | Apr 25, 2019 | |
| CISATRACURIUM BESYLATE | MEITHEAL | ANDA 211669 | AP | Apr 25, 2019 | |
| CISATRACURIUM BESYLATE | SOMERSET | ANDA 209132 | AP | Apr 24, 2019 | |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE×2 | SOMERSET THERAPS LLC | ANDA 206791 | AP | Feb 20, 2019 | |
| CISATRACURIUM BESYLATE×2 | HOSPIRA | ANDA 203236 | AP | Mar 30, 2018 | |
| CISATRACURIUM BESYLATE | HOSPIRA | ANDA 203238 | AP | Mar 30, 2018 | |
| CISATRACURIUM BESYLATE×3 | HENGRUI PHARMA | ANDA 204960 | — | Aug 30, 2017 | |
| CISATRACURIUM BESYLATE | ACCORD HLTHCARE | ANDA 205873 | — | Jun 16, 2017 | |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE×2 | ACCORD HLTHCARE | ANDA 205872 | — | Jun 16, 2017 | |
| CISATRACURIUM BESYLATE | FRESENIUS KABI USA | ANDA 203183 | AP | Feb 26, 2015 | |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE×2 | FRESENIUS KABI USA | ANDA 203182 | AP | Feb 26, 2015 | |
| CISATRACURIUM BESYLATE | SANDOZ INC | ANDA 200159 | AP | Feb 03, 2012 | |
| CISATRACURIUM BESYLATE PRESERVATIVE FREE×2 | SANDOZ INC | ANDA 200154 | AP | Feb 03, 2012 |
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.
Cisatracurium besylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
