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 1Amneal Pharmaceuticals
08 1Amnos Lifesciences
09 2Apotex Inc
10 4Appco Pharmaceutical Corp
11 3Avet Pharmaceuticals
12 1Baxter Healthcare Corporation
13 9Bayer AG
14 4Bristol Myers Squibb
15 3Cadila Pharmaceuticals
16 1Caplin Point Laboratories Limited
17 1Cooper Pharma Limited
18 2ENDO OPERATIONS LTD.
19 2Ebb Medical
20 3Epic Pharma. LLC.
21 4Farbe Firma
22 3Flagship Biotech International Pvt. Ltd
23 1GLAND PHARMA LIMITED
24 5GSK
25 3HIBROW HLTHCARE
26 2Health Biotech
27 7Hikma Pharmaceuticals
28 3Hospira, Inc.
29 1Igenius Life Sciences
30 1JAMP PHARMA
31 3Kern Pharma S.L.
32 2LABORATOIRE RIVA INC.
33 3Macleods Pharmaceuticals Limited
34 2Montage Laboratories
35 2Myungmoon Pharm. Co., LTD.
36 1ONESOURCE SPECIALTY
37 1ORIFARM GROUP AS
38 1Omega Laboratories Limited
39 3PH HEALTH
40 1Pfizer Inc
41 1Pluviaendo
42 2Rising Pharmaceuticals Inc
43 3Rubicon Research
44 1S.A.L.F. Spa Laboratorio Farmacologico
45 1STERIMAX INC
46 1Salfspa Pharmacological Laboratory
47 4Sandoz B2B
48 1Sebela Pharmaceuticals
49 3TEOFARMA Srl
50 3Teva Pharmaceutical Industries
51 1Themis Medicare
52 3Unichem Laboratories Limited
53 3Unichem Pharmaceuticals USA, Inc
54 4Verve Human Care Laboratories
55 3Zydus Lifesciences
56 3Zydus Pharmaceuticals
01 4Ampoule
02 2Antic-calc Tablet, Film Coated
03 2Coated Tablet
04 3Film Coated Tablet
05 1INJ
06 14INJECTABLE;INJECTION
07 2INJECTION
08 1Injectable And Infusion Solution
09 4Injectable Solution
10 10Injection
11 2Injection fluid, resolution
12 1Labetalol 100Mg 30 Joined' Oral Use
13 1Labetalol 200Mg 30 Joined' Oral Use
14 2Liquid Injection
15 5SOLUTION
16 6SOLUTION;INTRAVENOUS
17 1Solution For Injection/Infusion
18 1TAB
19 6TABLET
20 62TABLET;ORAL
21 12Tablet
22 2tablet
23 1Blank
01 3Allowed
02 5Approved
03 4Authorized
04 32DISCN
05 1Deregistered
06 8Generic
07 2Originator
08 11Prescription
09 50RX
10 29Blank
01 2APO-LABETALOL
02 60LABETALOL 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 1Labetalol S.A.L.F.
12 1Lobile
13 5NORMODYNE
14 4NORMOZIDE
15 3Overall
16 2Presolol 100
17 2RIVA-LABETALOL
18 7TRANDATE
19 4TRANDATE HCT
20 4The Tran Date
21 11Trandate
22 1Trandate Injection
23 1Trandiur
24 19Blank
01 2Australia
02 11Canada
03 25India
04 3Italy
05 4Norway
06 2South Africa
07 2South Korea
08 4Spain
09 6Sweden
10 3Switzerland
11 1Turkey
12 82USA
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 : 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
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 : 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 : 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
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
