Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 015921

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HALDOL (HALOPERIDOL)
0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015921
Product Number: 001
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL
Marketing Status:  Discontinued
Patent and Exclusivity Information

HALDOL (HALOPERIDOL)
1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015921
Product Number: 002
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL
Marketing Status:  Discontinued
Patent and Exclusivity Information

HALDOL (HALOPERIDOL)
2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015921
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL
Marketing Status:  Discontinued
Patent and Exclusivity Information

HALDOL (HALOPERIDOL)
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015921
Product Number: 004
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL
Marketing Status:  Discontinued
Patent and Exclusivity Information

HALDOL (HALOPERIDOL)
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015921
Product Number: 005
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL
Marketing Status:  Discontinued
Patent and Exclusivity Information

HALDOL (HALOPERIDOL)
20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N015921
Product Number: 006
Approval Date: Feb 2, 1982
Applicant Holder Full Name: ORTHO MCNEIL PHARMACEUTICAL
Marketing Status:  Discontinued
Patent and Exclusivity Information