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01 3Aspen API

02 7Aspen Pharmacare Holdings

03 3ANDAS 5 HOLDING

04 3Actavis Inc

05 2Alphapharm PTY Ltd

06 4Alvogen

07 1Amnos Lifesciences

08 2Apotex Inc

09 4Appco Pharmaceutical Corp

10 3Avet Pharmaceuticals

11 1Baxter Healthcare Corporation

12 9Bayer AG

13 4Bristol Myers Squibb

14 3Cadila Pharmaceuticals

15 1Caplin Point Laboratories Limited

16 1Cooper Pharma Limited

17 2ENDO OPERATIONS LTD.

18 2Ebb Medical

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 3Kern Pharma S.L.

31 2LABORATOIRE RIVA INC.

32 2Montage Laboratories

33 2Myungmoon Pharm. Co., LTD.

34 1ONESOURCE SPECIALTY

35 1ORIFARM GROUP AS

36 1Omega Laboratories Limited

37 3PH HEALTH

38 1Pfizer Inc

39 1Pluviaendo

40 2Rising Pharmaceuticals Inc

41 3Rubicon Research

42 1S.A.L.F. Spa Laboratorio Farmacologico

43 1STERIMAX INC

44 1Salfspa Pharmacological Laboratory

45 4Sandoz B2B

46 1Sebela Pharmaceuticals

47 3TEOFARMA Srl

48 3Teva Pharmaceutical Industries

49 1Themis Medicare

50 3Unichem Laboratories Limited

51 3Unichem Pharmaceuticals USA, Inc

52 4Verve Human Care Laboratories

53 3Zydus Lifesciences

54 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

PREP
Not Confirmed
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PREP
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

PREP
Not Confirmed
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PREP
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

PREP
Not Confirmed
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PREP
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

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14

PREP
Not Confirmed
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PREP
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

PREP
Not Confirmed
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PREP
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

PREP
Not Confirmed
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PREP
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

PREP
Not Confirmed
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PREP
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

PREP
Not Confirmed
arrow
arrow
PREP
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

PREP
Not Confirmed
arrow
arrow
PREP
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

PREP
Not Confirmed
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PREP
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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