Orange Book product · Brand (NDA)
INAPSINE
DROPERIDOL
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DROPERIDOL
Strength
2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 016796
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2017DROPERIDOLGeneric (ANDA)
ANDA 208197 · HIKMA
- 1995DROPERIDOLGeneric (ANDA)
ANDA 072272 · HOSPIRA
- 1991DROPERIDOLGeneric (ANDA)
ANDA 073520 · WATSON LABS
- 1991DROPERIDOLGeneric (ANDA)
ANDA 073521 · WATSON LABS
- 1991DROPERIDOLGeneric (ANDA)
ANDA 073523 · WATSON LABS
- 1988DROPERIDOLGeneric (ANDA)
ANDA 072123 · AM REGENT
- 1988DROPERIDOLGeneric (ANDA)
ANDA 072335 · LUITPOLD
- 1988DROPERIDOLGeneric (ANDA)
ANDA 072018 · ASTRAZENECA
- 1988DROPERIDOLGeneric (ANDA)
ANDA 072019 · IGI LABS INC
- 1988DROPERIDOLGeneric (ANDA)
ANDA 072020 · IGI LABS INC
- 1988DROPERIDOLGeneric (ANDA)
ANDA 072021 · IGI LABS INC
- 1988DROPERIDOLGeneric (ANDA)
ANDA 071750 · SMITH AND NEPHEW
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.
