Orange Book product · Brand (NDA)
HALDOL
HALOPERIDOL DECANOATE
At a glance
Jan 14, 1986
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 1986
41 yr ago
Today
Pharmaceutical detail
Active ingredient
HALOPERIDOL DECANOATE
Strength
EQ 50MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 018701
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.
- 2025HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 219168 · CAPLIN
- 2023HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 216730 · MANKIND PHARMA
- 2021HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 214507 · MEITHEAL
- 2019HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 211180 · ZYDUS PHARMS
- 2018HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 209101 · SOMERSET THERAPS LLC
- 2017HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 205241 · GLAND
- 2005HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 076463 · SANDOZ
- 2000HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 075440 · MYLAN LABS LTD
- 2000HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 075176 · HOSPIRA
- 1999HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 075393 · TEVA PHARMS USA
- 1998HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 075305 · HIKMA
- 1998HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 074811 · HIKMA
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.
