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01 6Aspen API

02 3Aspen Pharmacare Holdings

03 3ANDAS 5 HOLDING

04 3Actavis Inc

05 1Adcock Ingram

06 2Alphapharm PTY Ltd

07 4Alvogen

08 1Amnos Lifesciences

09 2Apotex Inc

10 4Appco Pharmaceutical Corp

11 3Avet Pharmaceuticals

12 1Baxter Healthcare Corporation

13 9Bayer AG

14 4Bristol Myers Squibb

15 3Cadila Pharmaceuticals

16 1Caplin Point Laboratories Limited

17 1Cooper Pharma Limited

18 3Endo International

19 3Epic Pharma. LLC.

20 4Farbe Firma

21 3Flagship Biotech International Pvt. Ltd

22 1GLAND PHARMA LIMITED

23 5GSK

24 3HIBROW HLTHCARE

25 2Health Biotech

26 7Hikma Pharmaceuticals

27 3Hospira, Inc.

28 1Igenius Life Sciences

29 1JAMP PHARMA

30 2Laboratoire Riva

31 2Montage Laboratories

32 2Myungmoon Pharm. Co., LTD.

33 1ORIFARM GROUP AS

34 1Omega Laboratories Limited

35 2PALADIN LABS

36 1Pfizer Inc

37 1Pluviaendo

38 2Rising Pharmaceuticals Inc

39 3Rubicon Research

40 1STERIMAX INC

41 4Sandoz B2B

42 1Sebela Pharmaceuticals

43 1Steriscience

44 3TEOFARMA Srl

45 3Teva Pharmaceutical Industries

46 1Themis Medicare

47 3Unichem Laboratories Limited

48 3Unichem Pharmaceuticals USA, Inc

49 4Verve Human Care Laboratories

50 3Zydus Lifesciences

51 3Zydus Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Regulatory Info :

Registration Country : Sweden

labetalol

Brand Name : Trandate

Dosage Form : TABLET

Dosage Strength : 100 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Aspen API Comapny Banner

03

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Regulatory Info :

Registration Country : Sweden

labetalol

Brand Name : Trandate

Dosage Form : SOLUTION FOR INJECTION

Dosage Strength : 5 MG / ML

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Aspen API Comapny Banner

04

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Regulatory Info :

Registration Country : Sweden

labetalol

Brand Name : Trandate

Dosage Form : TABLET

Dosage Strength : 200 MG

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Sweden

Aspen API Comapny Banner

05

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Regulatory Info :

Registration Country : Norway

Labetalol

Brand Name : The Tran Date

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 100 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Aspen API Comapny Banner

06

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Regulatory Info :

Registration Country : Norway

Labetalol

Brand Name : The Tran Date

Dosage Form : Antic-calc Tablet, Film Coated

Dosage Strength : 200 mg

Packaging : Box

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Aspen API Comapny Banner

07

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothAspen API. More than just an API™

Regulatory Info :

Registration Country : Norway

Labetalol

Brand Name : The Tran Date

Dosage Form : Injection fluid, resolution

Dosage Strength : 5 mg/ml

Packaging : Ampoule

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Norway

Aspen API Comapny Banner

09

Labetalol Hydrochloride

Brand Name : Trandate Injection

Dosage Form : INJ

Dosage Strength : 5mg/1ml

Packaging : 20X5mg/1ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

Aspen API Comapny Banner

10

APS Symposium
Not Confirmed
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APS Symposium
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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**

Packaging :

Approval Date : 1985-05-24

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

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11

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

blank

12

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

blank

13

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

blank

14

APS Symposium
Not Confirmed
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APS Symposium
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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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18686

Regulatory Info : DISCN

Registration Country : USA

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15

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1987-08-31

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

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16

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

blank

17

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

blank

18

APS Symposium
Not Confirmed
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APS Symposium
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

blank

19

APS Symposium
Not Confirmed
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APS Symposium
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HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Brand Name : NORMOZIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;100MG

Packaging :

Approval Date : 1987-04-06

Application Number : 19046

Regulatory Info : DISCN

Registration Country : USA

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20

APS Symposium
Not Confirmed
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APS Symposium
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HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE

Brand Name : NORMOZIDE

Dosage Form : TABLET;ORAL

Dosage Strength : 25MG;200MG

Packaging :

Approval Date : 1987-04-06

Application Number : 19046

Regulatory Info : DISCN

Registration Country : USA

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