FDA Orange Book · active-ingredient family
Droperidol
Droperidol is approved as 1 brand and 18 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:INAPSINE · NDA 016796
1
Brand (NDA)
18
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INAPSINERLD | RISING | NDA 016796 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (18)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DROPERIDOL | HIKMA | ANDA 208197 | AP | Dec 14, 2017 | |
| DROPERIDOL | HOSPIRA | ANDA 072272 | — | Aug 31, 1995 | |
| DROPERIDOL | WATSON LABS | ANDA 073520 | — | Nov 27, 1991 | |
| DROPERIDOL | WATSON LABS | ANDA 073521 | — | Nov 27, 1991 | |
| DROPERIDOL | WATSON LABS | ANDA 073523 | — | Nov 27, 1991 | |
| DROPERIDOL | AM REGENT | ANDA 072123 | AP | Oct 24, 1988 | |
| DROPERIDOL | LUITPOLD | ANDA 072335 | — | Oct 24, 1988 | |
| DROPERIDOL | ASTRAZENECA | ANDA 072018 | — | Oct 20, 1988 | |
| DROPERIDOL | IGI LABS INC | ANDA 072019 | — | Oct 19, 1988 | |
| DROPERIDOL | IGI LABS INC | ANDA 072020 | — | Oct 19, 1988 | |
| DROPERIDOL | IGI LABS INC | ANDA 072021 | — | Oct 19, 1988 | |
| DROPERIDOL | SMITH AND NEPHEW | ANDA 071750 | — | Sep 06, 1988 | |
| DROPERIDOL | SOLOPAK | ANDA 071754 | — | Sep 06, 1988 | |
| DROPERIDOL | SOLOPAK | ANDA 071755 | — | Sep 06, 1988 | |
| DROPERIDOL | HOSPIRA | ANDA 071645 | — | Apr 07, 1988 | |
| DROPERIDOL | HOSPIRA | ANDA 071981 | — | Feb 29, 1988 | |
| DROPERIDOL | ABRAXIS PHARM | ANDA 070992 | — | Nov 17, 1986 | |
| DROPERIDOL | ABRAXIS PHARM | ANDA 070993 | — | Nov 17, 1986 |
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.
Droperidol — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
