Orange Book product · Generic (ANDA)
HALOPERIDOL
HALOPERIDOL LACTATE
At a glance
Mar 09, 2001
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 09, 2001
25 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
HALOPERIDOL LACTATE
Strength
EQ 5MG BASE/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
AP
Application
ANDA 075689
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of HALOPERIDOL LACTATE
- —HALDOLBrand (NDA)
NDA 015922 · ORTHO MCNEIL
- —HALDOLBrand (NDA)
NDA 015923 · JANSSEN PHARMS
- 2024HALOPERIDOLGeneric (ANDA)
ANDA 218371 · RUBICON RESEARCH
- 2019HALOPERIDOLGeneric (ANDA)
ANDA 210356 · FRESENIUS KABI USA
- 2017HALOPERIDOLGeneric (ANDA)
ANDA 204849 · EPIC PHARMA LLC
- 2011HALOPERIDOLGeneric (ANDA)
ANDA 091637 · SAGENT PHARMS
- 2011HALOPERIDOLGeneric (ANDA)
ANDA 200742 · SAGENT PHARMS
- 2009HALOPERIDOLGeneric (ANDA)
ANDA 078347 · MYLAN LABS LTD
- 2004HALOPERIDOLGeneric (ANDA)
ANDA 076464 · FOSUN PHARMA
- 2004HALOPERIDOLGeneric (ANDA)
ANDA 076791 · BAXTER HLTHCARE CORP
- 2004HALOPERIDOLGeneric (ANDA)
ANDA 076828 · BAXTER HLTHCARE CORP
- 2004HALOPERIDOLGeneric (ANDA)
ANDA 076774 · GLAND PHARMA LTD
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.

