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01 2BRECKENRIDGE

02 2AARXION ANDA HLDING

03 2ACCORD HLTHCARE

04 2ADAPTIS

05 2ANNORA PHARMA

06 2CHARTWELL RX

07 2RISING

08 2SANDOZ

09 3UPJOHN

10 2WESTMINSTER PHARMS

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PharmaCompass

03

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2008-07-30

Application Number : 78482

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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04

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2008-07-30

Application Number : 78482

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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05

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : INSPRA

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2002-09-27

Application Number : 21437

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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06

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : INSPRA

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2002-09-27

Application Number : 21437

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : INSPRA

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG

Approval Date : 2002-09-27

Application Number : 21437

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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08

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2008-08-01

Application Number : 78510

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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09

DDL Conference
Not Confirmed
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DDL Conference
Not Confirmed

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 50MG

Approval Date : 2008-08-01

Application Number : 78510

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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10

AARXION ANDA HLDING

Country
DDL Conference
Not Confirmed
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AARXION ANDA HLDING

Country
arrow
DDL Conference
Not Confirmed

EPLERENONE

Brand Name : EPLERENONE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG

Approval Date : 2017-02-02

Application Number : 203896

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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