Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 071209

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HALOPERIDOL (HALOPERIDOL)
0.5MG
Marketing Status: Prescription

Active Ingredient: HALOPERIDOL
Proprietary Name: HALOPERIDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 0.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A071209
Product Number: 002
Approval Date: Nov 17, 1986
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HALOPERIDOL (HALOPERIDOL)
1MG
Marketing Status: Prescription

Active Ingredient: HALOPERIDOL
Proprietary Name: HALOPERIDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A071209
Product Number: 003
Approval Date: Nov 17, 1986
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HALOPERIDOL (HALOPERIDOL)
5MG
Marketing Status: Prescription

Active Ingredient: HALOPERIDOL
Proprietary Name: HALOPERIDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A071209
Product Number: 001
Approval Date: Nov 17, 1986
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

HALOPERIDOL (HALOPERIDOL)
2MG
Marketing Status: Discontinued

Active Ingredient: HALOPERIDOL
Proprietary Name: HALOPERIDOL
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A071209
Product Number: 004
Approval Date: Nov 17, 1986
Applicant Holder Full Name: CHARTWELL RX SCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information