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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 3HIBROW HLTHCARE

30 2Health Biotech

31 7Hikma Pharmaceuticals

32 3Hospira, Inc.

33 1Igenius Life Sciences

34 1JAMP PHARMA

35 3Kern Pharma S.L.

36 2Laboratoire Riva

37 3Macleods Pharmaceuticals Limited

38 2Montage Laboratories

39 2Myungmoon Pharm. Co., LTD.

40 1ONESOURCE SPECIALTY

41 1ORIFARM GROUP AS

42 1Omega Laboratories Limited

43 1P & D Pharmaceuticals Limited

44 3PH HEALTH

45 1Pfizer Inc

46 1Pluviaendo

47 2Rising Pharmaceuticals Inc

48 3Rubicon Research

49 1S.A.L.F SpA

50 1S.A.L.F. Spa Laboratorio Farmacologico

51 1STERIMAX INC

52 1Salfspa Pharmacological Laboratory

53 1Sandoz B2B

54 1Sebela Pharmaceuticals

55 3TEOFARMA Srl

56 3Teva Pharmaceutical Industries

57 1Themis Medicare

58 3Unichem Laboratories Limited

59 3Unichem Pharmaceuticals USA, Inc

60 3V.J. SALOMONE PHARMA LIMITED

61 4Verve Human Care Laboratories

62 3Zydus Lifesciences

63 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

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**

Packaging :

Approval Date : 1985-05-24

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

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12

CTAD25
Not Confirmed
arrow
arrow
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

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13

CTAD25
Not Confirmed
arrow
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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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

blank

14

CTAD25
Not Confirmed
arrow
arrow
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18716

Regulatory Info : DISCN

Registration Country : USA

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15

CTAD25
Not Confirmed
arrow
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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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18686

Regulatory Info : DISCN

Registration Country : USA

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16

CTAD25
Not Confirmed
arrow
arrow
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**

Packaging :

Approval Date : 1987-08-31

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

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17

CTAD25
Not Confirmed
arrow
arrow
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

blank

18

CTAD25
Not Confirmed
arrow
arrow
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

blank

19

CTAD25
Not Confirmed
arrow
arrow
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**

Packaging :

Approval Date : 1984-08-01

Application Number : 18687

Regulatory Info : DISCN

Registration Country : USA

blank

20

CTAD25
Not Confirmed
arrow
arrow
CTAD25
Not Confirmed

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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