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01 3AIPING PHARM INC

02 4ALVOGEN

03 1AMNEAL

04 3ANDAS 5 HOLDING

05 4APOTHECON

06 4APPCO

07 1BAXTER HLTHCARE CORP

08 3CADILA PHARMS LTD

09 1CAPLIN

10 3EPIC PHARMA LLC

11 1GLAND PHARMA LTD

12 4GLAXOSMITHKLINE

13 3HERITAGE PHARMA

14 3HIBROW HLTHCARE

15 7HIKMA

16 3HOSPIRA

17 3MACLEODS PHARMS LTD

18 1ONESOURCE SPECIALTY

19 3PH HEALTH

20 2RISING

21 3RUBICON RESEARCH

22 9SCHERING

23 1SEBELA IRELAND LTD

24 3TEVA

25 3UNICHEM

26 3WATSON LABS

27 3ZYDUS PHARMS

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PharmaCompass

01

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : TRANDATE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1985-05-24

Application Number : 18716

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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02

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : TRANDATE

Dosage Form : TABLET;ORAL

Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-08-01

Application Number : 18716

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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03

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : TRANDATE

Dosage Form : TABLET;ORAL

Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-08-01

Application Number : 18716

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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04

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : TRANDATE

Dosage Form : TABLET;ORAL

Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-08-01

Application Number : 18716

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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05

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : NORMODYNE

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-08-01

Application Number : 18686

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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06

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : NORMODYNE

Dosage Form : TABLET;ORAL

Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1987-08-31

Application Number : 18687

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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07

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : NORMODYNE

Dosage Form : TABLET;ORAL

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

Approval Date : 1984-08-01

Application Number : 18687

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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08

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : NORMODYNE

Dosage Form : TABLET;ORAL

Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Approval Date : 1984-08-01

Application Number : 18687

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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09

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

LABETALOL HYDROCHLORIDE

Brand Name : NORMODYNE

Dosage Form : TABLET;ORAL

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

Approval Date : 1984-08-01

Application Number : 18687

RX/OTC/DISCN : DISCN

RLD : Yes

TE Code :

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10

CTAD25
Not Confirmed
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CTAD25
Not Confirmed

HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Brand Name : NORMOZIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;100MG

Approval Date : 1987-04-06

Application Number : 19046

RX/OTC/DISCN : DISCN

RLD : No

TE Code :

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