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01 6Aspen API

02 3Aspen 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 3ENDO OPERATIONS

18 3Epic Pharma. LLC.

19 4Farbe Firma

20 3Flagship Biotech International Pvt. Ltd

21 1GLAND PHARMA LIMITED

22 5GSK

23 3HIBROW HLTHCARE

24 2Health Biotech

25 7Hikma Pharmaceuticals

26 3Hospira, Inc.

27 1Igenius Life Sciences

28 1JAMP PHARMA

29 2LABORATOIRE RIVA INC.

30 2Montage Laboratories

31 2Myungmoon Pharm. Co., LTD.

32 1ORIFARM GROUP AS

33 1Omega Laboratories Limited

34 2PALADIN PHARMA INC.

35 1Pfizer Inc

36 1Pluviaendo

37 2Rising Pharmaceuticals Inc

38 3Rubicon Research

39 1STERIMAX INC

40 1STERISCIENCE SPECLTS

41 4Sandoz B2B

42 1Sebela Pharmaceuticals

43 3TEOFARMA Srl

44 3Teva Pharmaceutical Industries

45 1Themis Medicare

46 3Unichem Laboratories Limited

47 3Unichem Pharmaceuticals USA, Inc

48 4Verve Human Care Laboratories

49 3Zydus Lifesciences

50 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

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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11

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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12

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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14

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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15

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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

AACR Annual meeting
Not Confirmed
arrow
arrow
AACR Annual meeting
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

AACR Annual meeting
Not Confirmed
arrow
arrow
AACR Annual meeting
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

AACR Annual meeting
Not Confirmed
arrow
arrow
AACR Annual meeting
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

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
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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20

AACR Annual meeting
Not Confirmed
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AACR Annual meeting
Not Confirmed

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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