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01 4ALVOGEN

02 3ANDAS 5 HOLDING

03 4APOTHECON

04 4APPCO

05 1BAXTER HLTHCARE CORP

06 3CADILA PHARMS LTD

07 1CAPLIN

08 3EPIC PHARMA LLC

09 1GLAND PHARMA LTD

10 4GLAXOSMITHKLINE

11 3HERITAGE PHARMA

12 3HIBROW HLTHCARE

13 7HIKMA

14 3HOSPIRA

15 1ONESOURCE SPECIALTY

16 3PH HEALTH

17 2RISING

18 3RUBICON RESEARCH

19 3SANDOZ

20 9SCHERING

21 1SEBELA IRELAND LTD

22 3TEVA

23 3UNICHEM

24 3WATSON LABS

25 3ZYDUS PHARMS

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PharmaCompass

01

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Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

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Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

iPHEX India
Not Confirmed
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iPHEX India
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

iPHEX India
Not Confirmed
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iPHEX India
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

iPHEX India
Not Confirmed
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iPHEX India
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

iPHEX India
Not Confirmed
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iPHEX India
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

iPHEX India
Not Confirmed
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iPHEX India
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

iPHEX India
Not Confirmed
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iPHEX India
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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