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01 3Aspen API

02 7Aspen Pharmacare Holdings

03 3ANDAS 5 HOLDING

04 3Actavis Inc

05 1Adcock Ingram

06 3AiPing Pharmaceutical Inc

07 2Alphapharm PTY Ltd

08 4Alvogen

09 1Amneal Pharmaceuticals

10 1Amnos Lifesciences

11 2Apotex Inc

12 4Appco Pharmaceutical Corp

13 3Avet Pharmaceuticals

14 1Baxter Healthcare Corporation

15 9Bayer AG

16 4Bristol Myers Squibb

17 3Cadila Pharmaceuticals

18 1Caplin Point Laboratories Limited

19 3Central Procurement & Supplies Unit

20 4Cherubino Limited

21 1Cooper Pharma Limited

22 2Ebb Medical

23 2Endo International

24 3Epic Pharma. LLC.

25 4Farbe Firma

26 3Flagship Biotech International Pvt. Ltd

27 1GLAND PHARMA LIMITED

28 5GSK

29 1Genex Pharma

30 3HIBROW HLTHCARE

31 2Health Biotech

32 7Hikma Pharmaceuticals

33 3Hospira, Inc.

34 1Igenius Life Sciences

35 1JAMP PHARMA

36 3Kern Pharma S.L.

37 2Laboratoire Riva

38 3Macleods Pharmaceuticals Limited

39 2Montage Laboratories

40 2Myungmoon Pharm. Co., LTD.

41 1ONESOURCE SPECIALTY

42 1ORIFARM GROUP AS

43 1Omega Laboratories Limited

44 1P & D Pharmaceuticals Limited

45 3PH HEALTH

46 1Pfizer Inc

47 1Pluviaendo

48 2Rising Pharmaceuticals Inc

49 3Rubicon Research

50 1S.A.L.F SpA

51 1S.A.L.F. Spa Laboratorio Farmacologico

52 1STERIMAX INC

53 1Salfspa Pharmacological Laboratory

54 1Sandoz B2B

55 1Sebela Pharmaceuticals

56 3TEOFARMA Srl

57 3Teva Pharmaceutical Industries

58 1Themis Medicare

59 3Unichem Laboratories Limited

60 3Unichem Pharmaceuticals USA, Inc

61 3V.J. SALOMONE PHARMA LIMITED

62 4Verve Human Care Laboratories

63 3Zydus Lifesciences

64 3Zydus Pharmaceuticals

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PharmaCompass

01

  • 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

02

Labetalol Hydrochloride

Brand Name : Trandate

Dosage Form : Film Coated Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 18/12/1981

Application Number : 19811218000021

Regulatory Info : Approved

Registration Country : Sweden

Aspen API Comapny Banner

03

  • 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

04

  • 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

05

Labetalol Hydrochloride

Brand Name : Trandate

Dosage Form : Film Coated Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 18/12/1981

Application Number : 19811218000038

Regulatory Info : Approved

Registration Country : Sweden

Aspen API Comapny Banner

06

Labetalol Hydrochloride

Brand Name : Trandate

Dosage Form : Injectable Solution

Dosage Strength : 5mg/ml

Packaging :

Approval Date : 18/12/1981

Application Number : 19811218000045

Regulatory Info : Approved

Registration Country : Sweden

Aspen API Comapny Banner

07

Labetalol Hydrochloride

Brand Name : Trandate

Dosage Form : Injectable Solution

Dosage Strength : 100mg/20ml

Packaging :

Approval Date : 23/10/1979

Application Number : 41529

Regulatory Info : Allowed

Registration Country : Switzerland

Aspen API Comapny Banner

08

Labetalol Hydrochloride

Brand Name : Trandate

Dosage Form : Tablet

Dosage Strength : 100mg

Packaging :

Approval Date : 05/12/1978

Application Number : 41530

Regulatory Info : Allowed

Registration Country : Switzerland

Aspen API Comapny Banner

09

Labetalol Hydrochloride

Brand Name : Trandate

Dosage Form : Tablet

Dosage Strength : 200mg

Packaging :

Approval Date : 05/12/1978

Application Number : 41530

Regulatory Info : Allowed

Registration Country : Switzerland

Aspen API Comapny Banner

10

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

11

Global ChemShow
Not Confirmed
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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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12

Global ChemShow
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Global ChemShow
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

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13

Global ChemShow
Not Confirmed
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Global ChemShow
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

14

Global ChemShow
Not Confirmed
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Global ChemShow
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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

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15

Global ChemShow
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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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16

Global ChemShow
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Global ChemShow
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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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17

Global ChemShow
Not Confirmed
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Global ChemShow
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

18

Global ChemShow
Not Confirmed
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Global ChemShow
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

19

Global ChemShow
Not Confirmed
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Global ChemShow
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

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20

Global ChemShow
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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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