Orange Book product · Brand (NDA)
HALDOL
HALOPERIDOL
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
Strength
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 015921
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.
- —HALDOL SOLUTABBrand (NDA)
NDA 017079 · ORTHO MCNEIL PHARM
- 2026HALOPERIDOLGeneric (ANDA)
ANDA 214470 · ALEMBIC
- 2026HALOPERIDOLGeneric (ANDA)
ANDA 071130 · AIPING PHARM INC
- 2025HALOPERIDOLGeneric (ANDA)
ANDA 218162 · CREEKWOOD PHARMS
- 2024HALOPERIDOLGeneric (ANDA)
ANDA 218789 · AUROBINDO PHARMA LTD
- 2024HALOPERIDOLGeneric (ANDA)
ANDA 216918 · MANKIND PHARMA
- 2022HALOPERIDOLGeneric (ANDA)
ANDA 216004 · MSN
- 2022HALOPERIDOLGeneric (ANDA)
ANDA 200854 · ACTAVIS GROUP
- 2020HALOPERIDOLGeneric (ANDA)
ANDA 211061 · APPCO
- 1989HALOPERIDOLGeneric (ANDA)
ANDA 072727 · LEDERLE
- 1989HALOPERIDOLGeneric (ANDA)
ANDA 072728 · LEDERLE
- 1989HALOPERIDOLGeneric (ANDA)
ANDA 072729 · LEDERLE
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.
