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Generic Haldol Availability

Haldol is a brand name of haloperidol, approved by the FDA in the following formulation(s):

HALDOL (haloperidol - tablet;oral)

  • Manufacturer: ORTHO MCNEIL
    Approved Prior to Jan 1, 1982
    Strength(s): 0.5MG (discontinued) [RLD], 1MG (discontinued) [RLD], 2MG (discontinued) [RLD], 5MG (discontinued) [RLD], 10MG (discontinued) [RLD]
  • Manufacturer: ORTHO MCNEIL
    Approval date: February 2, 1982
    Strength(s): 20MG (discontinued) [RLD]

HALDOL (haloperidol decanoate - injectable;injection)

  • Manufacturer: JANSSEN PHARMS
    Approval date: January 14, 1986
    Strength(s): EQ 50MG BASE/ML [RLD] [AO]
  • Manufacturer: JANSSEN PHARMS
    Approval date: January 31, 1997
    Strength(s): EQ 100MG BASE/ML [RLD] [AO]

HALDOL (haloperidol lactate - concentrate;oral)

  • Manufacturer: ORTHO MCNEIL
    Approved Prior to Jan 1, 1982
    Strength(s): EQ 2MG BASE/ML (discontinued)

HALDOL (haloperidol lactate - injectable;injection)

  • Manufacturer: JANSSEN PHARMS
    Approved Prior to Jan 1, 1982
    Strength(s): EQ 5MG BASE/ML (discontinued) [RLD]

Has a generic version of Haldol been approved?

Yes. The following products are equivalent to Haldol:

haloperidol decanoate injectable;injection

  • Manufacturer: FRESENIUS KABI USA
    Approval date: December 19, 1997
    Strength(s): EQ 50MG BASE/ML [AO], EQ 100MG BASE/ML [AO]
  • Manufacturer: GLAND PHARMA LTD
    Approval date: May 12, 2017
    Strength(s): EQ 50MG BASE/ML [AO], EQ 100MG BASE/ML [AO]
  • Manufacturer: MYLAN LABS LTD
    Approval date: February 28, 2000
    Strength(s): EQ 50MG BASE/ML [AO], EQ 100MG BASE/ML [AO]
  • Manufacturer: SOMERSET THERAPS LLC
    Approval date: July 3, 2018
    Strength(s): EQ 50MG BASE/ML [AO], EQ 100MG BASE/ML [AO]
  • Manufacturer: TEVA PHARMS USA
    Approval date: May 11, 1999
    Strength(s): EQ 50MG BASE/ML [AO], EQ 100MG BASE/ML [AO]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: January 30, 1998
    Strength(s): EQ 50MG BASE/ML [AO]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: September 28, 1998
    Strength(s): EQ 100MG BASE/ML [AO]
  • Manufacturer: ZYDUS PHARMS
    Approval date: October 22, 2019
    Strength(s): EQ 50MG BASE/ML [AO], EQ 100MG BASE/ML [AO]

Note: No generic formulation of the following products are available.

  • haloperidol - tablet;oral
  • haloperidol lactate - concentrate;oral
  • haloperidol lactate - injectable;injection

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Haldol. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQs.

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AO Injectable oil solutions. The absorption of drugs in injectable (parenteral) oil solutions may vary substantially with the type of oil employed as a vehicle and the concentration of the active ingredient. Injectable oil solutions are therefore considered to be pharmaceutically and therapeutically equivalent only when the active ingredient, its concentration, and the type of oil used as a vehicle are all identical.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.