Orange Book product · Generic (ANDA)
HALOPERIDOL DECANOATE
HALOPERIDOL DECANOATE
At a glance
May 23, 2023
Approved
Generic (ANDA)
Application
AO
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
May 23, 2023
3 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
HALOPERIDOL DECANOATE
Strength
EQ 50MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AO
Application
ANDA 216730
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of HALOPERIDOL DECANOATE
- 1986HALDOLBrand (NDA)
NDA 018701 · JANSSEN PHARMS
- 2025HALOPERIDOL DECANOATEGeneric (ANDA)
ANDA 219168 · CAPLIN
- 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.
