Orange Book product · Brand (NDA)
HALDOL
HALOPERIDOL LACTATE
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
HALOPERIDOL LACTATE
Strength
EQ 5MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 015923
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.
- —HALDOLBrand (NDA)
NDA 015922 · ORTHO MCNEIL
- 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
- 2001HALOPERIDOLGeneric (ANDA)
ANDA 076035 · TEVA PHARMS USA
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.
