FDA Orange Book · active-ingredient family
Vecuronium bromide
Vecuronium bromide is approved as 1 brand and 12 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NORCURON · NDA 018776
1
Brand (NDA)
12
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NORCURONRLD×2 | ORGANON USA INC | NDA 018776 | — | Apr 30, 1984 |
Generic (ANDA) products (12)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| VECURONIUM BROMIDE×2 | HIKMA | ANDA 203725 | AP | Jul 30, 2019 | |
| VECURONIUM BROMIDE×2 | EUGIA PHARMA | ANDA 206670 | AP | Dec 20, 2018 | |
| VECURONIUM BROMIDE×2 | GLAND | ANDA 205390 | AP | May 26, 2016 | |
| VECURONIUM BROMIDE×2 | MYLAN LABS LTD | ANDA 090243 | AP | May 11, 2010 | |
| VECURONIUM BROMIDE×2 | SUN PHARM | ANDA 079001 | AP | Jun 17, 2009 | |
| VECURONIUM BROMIDE×2 | SAGENT PHARMS INC | ANDA 078274 | AP | Dec 29, 2008 | |
| VECURONIUM BROMIDE | HOSPIRA | ANDA 075558 | — | Sep 11, 2001 | |
| VECURONIUM BROMIDE×2 | HIKMA | ANDA 075549 | AP | Jun 13, 2000 | |
| VECURONIUM BROMIDE×2 | HOSPIRA | ANDA 075164 | AP | Oct 21, 1999 | |
| VECURONIUM BROMIDE×2 | MEITHEAL | ANDA 074688 | AP | Aug 25, 1999 | |
| VECURONIUM BROMIDE×2 | HIKMA | ANDA 075218 | — | Aug 23, 1999 | |
| VECURONIUM BROMIDE×2 | WATSON LABS | ANDA 074334 | — | Aug 31, 1995 |
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.
Vecuronium bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
