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Approved Drug Products containing Acebutolol HCl listed in the FDA Orange Book. Original Data : FDA Website

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01 2PROMIUS PHARMA

02 2AMNEAL PHARM

03 2ANI PHARMS

04 2NORVIUM BIOSCIENCE

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01

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : SECTRAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-12-28

Application Number : 18917

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Dr. Reddy Company Banner

02

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : SECTRAL

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-12-28

Application Number : 18917

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

Dr. Reddy Company Banner

03

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : ACEBUTOLOL HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 1999-12-30

Application Number : 75047

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : ACEBUTOLOL HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 1999-12-30

Application Number : 75047

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : ACEBUTOLOL HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 1995-10-18

Application Number : 74007

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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06

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : ACEBUTOLOL HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 1995-10-18

Application Number : 74007

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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07

NORVIUM BIOSCIENCE

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NORVIUM BIOSCIENCE

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : ACEBUTOLOL HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 200MG BASE

Approval Date : 1995-04-24

Application Number : 74288

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

NORVIUM BIOSCIENCE

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NORVIUM BIOSCIENCE

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ACEBUTOLOL HYDROCHLORIDE

Brand Name : ACEBUTOLOL HYDROCHLORIDE

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 400MG BASE

Approval Date : 1995-04-24

Application Number : 74288

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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