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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 205241

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HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
EQ 50MG BASE/ML
Marketing Status: Prescription
Active Ingredient: HALOPERIDOL DECANOATE
Proprietary Name: HALOPERIDOL DECANOATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 50MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AO
Application Number: A205241
Product Number: 001
Approval Date: May 12, 2017
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
HALOPERIDOL DECANOATE (HALOPERIDOL DECANOATE)
EQ 100MG BASE/ML
Marketing Status: Prescription
Active Ingredient: HALOPERIDOL DECANOATE
Proprietary Name: HALOPERIDOL DECANOATE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: EQ 100MG BASE/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AO
Application Number: A205241
Product Number: 002
Approval Date: May 12, 2017
Applicant Holder Full Name: GLAND PHARMA LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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