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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 3ENDO OPERATIONS

09 3EPIC PHARMA LLC

10 1GLAND PHARMA LTD

11 4GLAXOSMITHKLINE

12 3HERITAGE PHARMA

13 3HIBROW HLTHCARE

14 7HIKMA

15 3HOSPIRA

16 2RISING

17 3RUBICON

18 3SANDOZ

19 9SCHERING

20 1SEBELA IRELAND LTD

21 1STERISCIENCE SPECLTS

22 3TEVA

23 3UNICHEM

24 3WATSON LABS

25 3ZYDUS PHARMS

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PharmaCompass

01

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Dosage Strength : 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Dosage Strength : 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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Dosage Strength : 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2024 ACI Convention
Not Confirmed
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arrow
2024 ACI Convention
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Dosage Strength : 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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 :

blank

08

2024 ACI Convention
Not Confirmed
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arrow
2024 ACI Convention
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 :

blank

09

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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

2024 ACI Convention
Not Confirmed
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2024 ACI Convention
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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