Aspen API. More than just an API™
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 2LABORATOIRE RIVA INC.
31 2Montage Laboratories
32 2Myungmoon Pharm. Co., LTD.
33 1ONESOURCE SPECIALTY
34 1ORIFARM GROUP AS
35 1Omega Laboratories Limited
36 3PH HEALTH
37 1Pfizer Inc
38 1Pluviaendo
39 2Rising Pharmaceuticals Inc
40 3Rubicon Research
41 1S.A.L.F. Spa Laboratorio Farmacologico
42 1STERIMAX INC
43 4Sandoz B2B
44 1Sebela Pharmaceuticals
45 3TEOFARMA Srl
46 3Teva Pharmaceutical Industries
47 1Themis Medicare
48 3Unichem Laboratories Limited
49 3Unichem Pharmaceuticals USA, Inc
50 4Verve Human Care Laboratories
51 3Zydus Lifesciences
52 3Zydus Pharmaceuticals
01 4Ampoule
02 2Antic-calc Tablet, Film Coated
03 3Film Coated Tablet
04 1INJ
05 13INJECTABLE;INJECTION
06 2INJECTION
07 3Injectable Solution
08 10Injection
09 2Injection fluid, resolution
10 1Labetalol 100Mg 30 Joined' Oral Use
11 1Labetalol 200Mg 30 Joined' Oral Use
12 2Liquid Injection
13 5SOLUTION
14 6SOLUTION;INTRAVENOUS
15 1Solution For Injection/Infusion
16 1TAB
17 6TABLET
18 59TABLET;ORAL
19 12Tablet
20 2tablet
21 1Blank
01 3Allowed
02 5Approved
03 32DISCN
04 1Deregistered
05 8Generic
06 2Originator
07 46RX
08 40Blank
01 2APO-LABETALOL
02 56LABETALOL HYDROCHLORIDE
03 1LABETALOL HYDROCHLORIDE IN DEXTROSE
04 3LABETALOL HYDROCHLORIDE IN SODIUM CHLORIDE
05 1LABETALOL HYDROCHLORIDE INJECTION
06 4LABETALOL HYDROCHLORIDE INJECTION USP
07 4LABEVER
08 2Labesin
09 2Labetalol
10 1Labetalol Ointment
11 1Lobile
12 5NORMODYNE
13 4NORMOZIDE
14 2Presolol 100
15 2RIVA-LABETALOL
16 7TRANDATE
17 4TRANDATE HCT
18 4The Tran Date
19 11Trandate
20 1Trandate Injection
21 1Trandiur
22 19Blank
01 2Australia
02 11Canada
03 25India
04 3Italy
05 4Norway
06 2South Africa
07 2South Korea
08 6Sweden
09 3Switzerland
10 1Turkey
11 78USA
Aspen API. More than just an API™
Regulatory Info :
Registration Country : Norway
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
Regulatory Info : Originator
Registration Country : South Africa
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. More than just an API™
Regulatory Info :
Registration Country : Norway
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. More than just an API™
Regulatory Info :
Registration Country : Norway
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Approved
Registration Country : Sweden
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
Regulatory Info : Allowed
Registration Country : Switzerland
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
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Trandate
Dosage Form : Tablet
Dosage Strength : 100mg
Packaging :
Approval Date : 05/12/1978
Application Number : 41530
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Allowed
Registration Country : Switzerland
Brand Name : Trandate
Dosage Form : Tablet
Dosage Strength : 200mg
Packaging :
Approval Date : 05/12/1978
Application Number : 41530
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
Regulatory Info : DISCN
Registration Country : USA
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
