Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 075047

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ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL HYDROCHLORIDE)
EQ 200MG BASE
Marketing Status: Prescription

Active Ingredient: ACEBUTOLOL HYDROCHLORIDE
Proprietary Name: ACEBUTOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 200MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A075047
Product Number: 001
Approval Date: Dec 30, 1999
Applicant Holder Full Name: AMNEAL PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information

ACEBUTOLOL HYDROCHLORIDE (ACEBUTOLOL HYDROCHLORIDE)
EQ 400MG BASE
Marketing Status: Prescription

Active Ingredient: ACEBUTOLOL HYDROCHLORIDE
Proprietary Name: ACEBUTOLOL HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: EQ 400MG BASE
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A075047
Product Number: 002
Approval Date: Dec 30, 1999
Applicant Holder Full Name: AMNEAL PHARMACEUTICAL
Marketing Status:  Prescription
Patent and Exclusivity Information