FDA Orange Book · active-ingredient family
Pancuronium bromide
Pancuronium bromide 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:PAVULON · NDA 017015
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PAVULONRLD×2 | ORGANON USA INC | NDA 017015 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| PANCURONIUM BROMIDE | DR REDDYS | ANDA 072759 | — | Jul 31, 1990 | |
| PANCURONIUM BROMIDE | DR REDDYS | ANDA 072760 | — | Jul 31, 1990 | |
| PANCURONIUM BROMIDE | HOSPIRA | ANDA 072320 | — | Jan 19, 1989 | |
| PANCURONIUM BROMIDE | HOSPIRA | ANDA 072321 | — | Jan 19, 1989 | |
| PANCURONIUM BROMIDE | IGI LABS INC | ANDA 072210 | — | Mar 31, 1988 | |
| PANCURONIUM BROMIDE | IGI LABS INC | ANDA 072211 | — | Mar 31, 1988 | |
| PANCURONIUM BROMIDE | IGI LABS INC | ANDA 072212 | — | Mar 31, 1988 | |
| PANCURONIUM BROMIDE | IGI LABS INC | ANDA 072213 | — | Mar 31, 1988 | |
| PANCURONIUM BROMIDE | ELKINS SINN | ANDA 072058 | — | Mar 23, 1988 | |
| PANCURONIUM BROMIDE | ELKINS SINN | ANDA 072059 | — | Mar 23, 1988 | |
| PANCURONIUM BROMIDE | ELKINS SINN | ANDA 072060 | — | Mar 23, 1988 |
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.
Pancuronium bromide — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
