01 1Aspen Pharmacare Holdings
02 10Orion Corporation
03 2Ethypharm
04 4Ever Pharma
05 5Accord healthcare
06 1Actavis Inc
07 4Altan Pharma
08 1American Regent
09 4Amneal Pharmaceuticals
10 1Auro Pharma Inc
11 3Aurobindo Pharma Limited
12 6B. Braun Melsungen AG
13 3Baxter Healthcare Corporation
14 3Bayer AG
15 2BioXcel Therapeutics
16 2Cuckos
17 2DECHRA VETERINARY PRODUCTS AS
18 1Darou Darman Arang
19 1Dong Bang Co., Ltd
20 1EQL Pharma
21 1Eugia Pharma
22 1Eurofarma Laboratorios S.A
23 1Forrester Pharma
24 3Fresenius Kabi AB Brunna
25 3Fresenius Kabi AG
26 5Fresenius Kabi USA
27 3GLAND PHARMA LIMITED
28 1Grey Wolf Animal Health
29 4HQ SPCLT PHARMA
30 8Hikma Pharmaceuticals
31 5Hospira, Inc.
32 6Jiangsu Hengrui Medicine
33 4Juno Pharmaceuticals Pty Ltd
34 2Kalcex
35 1LABORATORIOS NORMON SA
36 3Labatec Pharm
37 1Lorien Laboratories Sl
38 2MODERN VETERINARY THERAPEUTICS LLC
39 1Meitheal Pharmaceuticals
40 2Milla Pharmaceuticals
41 1Montage Laboratories
42 3Orion Pharma
43 3PH HEALTH
44 3Pfizer Inc
45 1Pharmacorp
46 1Piramal Enterprises Limited
47 1Polifarma
48 2Recipharm AB
49 1Rising Pharmaceuticals Inc
50 1Sandoz B2B
51 2Somerset Pharmaceuticals Inc
52 1Sun Pharmaceutical Industries Limited
53 3Tagi Pharma
54 3Teva Pharmaceutical Industries
55 3Themis Medicare
56 5Viatris
57 3WILSHIRE PHARMS INC
58 1Yichang Humanwell Pharmaceutical
59 1Zydus Pharmaceuticals
60 1Blank
01 1Concentated Solution For IV Infusion
02 5Concentrate For Infusion Solution
03 30Concentrate For Solution For Infusion
04 1Concentrate for Solution for Infusion
05 4Concentrate to the infusion fluid, resolution
06 2FILM;BUCCAL, SUBLINGUAL
07 1GEL
08 3INF
09 6INJ
10 53INJECTABLE;INJECTION
11 3Infusion Solution
12 1Injectable
13 2Injectable Solution
14 9Injection
15 1Liquid Injection
16 16SOLUTION
17 6SOLUTION;INTRAVENOUS
18 2Solution For Infusion
19 3Solution For Injection
20 3Solution For Perfusion
21 1Solution for Infusion
22 1Vial
01 10Allowed
02 12Approved
03 2Authorised
04 18Authorized
05 1Cancelled
06 3DISCN
07 3Deregistered
08 8Generic
09 1Originator
10 17Prescription
11 57RX
12 2US ANDA- Submitted
13 20Blank
01 1Aro-midin
02 1CEPETOR
03 1DEMETEV
04 1DEXDOMITOR
05 1DEXISUN
06 1DEXMEDESED
07 54DEXMEDETOMIDINE HYDROCHLORIDE
08 3DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
09 2DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP
10 3DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
11 1DEXVETIDINE
12 1Demodinex
13 8Dexdor
14 1Dexdor 1000ugml
15 1Dexdor 200ugml
16 1Dexdor 400ugml
17 1Dexem 0.5
18 1Dexem 1
19 1Dexem 2
20 1Dexmedetomidin Fresenius iv 200ugml
21 1Dexmedetomidina Accord
22 2Dexmedetomidina Altan
23 3Dexmedetomidina B. Braun
24 1Dexmedetomidina Baxter
25 1Dexmedetomidina Ever Pharma
26 3Dexmedetomidina Hikma
27 1Dexmedetomidina Kabi
28 1Dexmedetomidina Kalceks
29 1Dexmedetomidina Lorien
30 1Dexmedetomidina Normon
31 1Dexmedetomidina Rph Pharma
32 2Dexmedetomidine
33 1Dexmedetomidine Accord
34 1Dexmedetomidine Altan
35 1Dexmedetomidine Altan Pharma
36 3Dexmedetomidine B. Braun
37 1Dexmedetomidine Baxter
38 1Dexmedetomidine Baxter ?g
39 1Dexmedetomidine Eql Pharma
40 1Dexmedetomidine Ever Pharma
41 1Dexmedetomidine Ever Valinject
42 1Dexmedetomidine Fresenius iv 1000ugml
43 1Dexmedetomidine Fresenius iv 400ugml
44 1Dexmedetomidine Hydrochloride
45 2Dexmedetomidine Kabi
46 1Dexmedetomidine Kalceks
47 3Dexmedetomidine Labatec ?g
48 1Dexmedetomidine Rph Pharma
49 1Dexmedetomidine Teva
50 1Dexmedetomidine Viatris
51 1Eccladex
52 2IGALMI
53 1Medetin
54 7PRECEDEX
55 1Precedex
56 1Precia
57 1SEDAJECT
58 1SILEO
59 1Sedalpha 100 µg/ml
60 1Sedmedex 100 µg/ml
61 1TOMEXA 200 μg/2 ml
62 1ZENALPHA
63 9Blank
01 1Austria
02 2Brazil
03 17Canada
04 3China
05 2France
06 6India
07 1Iran
08 2Malta
09 4Norway
10 9South Africa
11 1South Korea
12 19Spain
13 15Sweden
14 10Switzerland
15 1Turkey
16 61USA
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Eccladex
Dosage Form : INF
Dosage Strength : 100mcg/ml
Packaging : 2X5mcg/ml
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Solution for Infusion
Dosage Strength : 4MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info :
Registration Country : Austria
Brand Name :
Dosage Form : Concentrate for Solution for Infusion
Dosage Strength : 100MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Hood glass
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Brand Name : Dexdor
Dosage Form : Concentrate to the infusion fluid, resolution
Dosage Strength : 100 mcg/ml
Packaging : Ampoule
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dexdor
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100mcg/ml
Packaging :
Approval Date : 16/09/2011
Application Number : 20101005000010
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexdor
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2018-09-17
Application Number : 111718004
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexdor
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2011-11-10
Application Number : 11718006
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexdor
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2011-11-10
Application Number : 11718002
Regulatory Info : Authorized
Registration Country : Spain
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : DEXDOMITOR
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging : 10ML
Approval Date :
Application Number : 2333929
Regulatory Info : Prescription
Registration Country : Canada
Regulatory Info : Prescription
Registration Country : Canada
Brand Name : SILEO
Dosage Form : GEL
Dosage Strength : 0.1MG/ML
Packaging :
Approval Date :
Application Number : 2530392
Regulatory Info : Prescription
Registration Country : Canada
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Vial
Dosage Strength : 100MCG/ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Dexmedetomidine Ever Pharma
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100mcg/ml
Packaging :
Approval Date : 08/02/2018
Application Number : 20160402000092
Regulatory Info : Approved
Registration Country : Sweden
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Authorized
Registration Country : Spain
Brand Name : Dexmedetomidina Ever Pharma
Dosage Form : Concentrate For Infusion Solution
Dosage Strength : 100MCG
Packaging :
Approval Date : 2018-03-22
Application Number : 82586
Regulatory Info : Authorized
Registration Country : Spain
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Authorised
Registration Country : Malta
Brand Name : Dexmedetomidine Ever Valinject
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100MCG/ML
Packaging :
Approval Date : 2022-12-09
Application Number :
Regulatory Info : Authorised
Registration Country : Malta
Regulatory Info : RX
Registration Country : USA
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Packaging :
Approval Date : 1999-12-17
Application Number : 21038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
Packaging :
Approval Date : 2013-03-13
Application Number : 21038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Packaging :
Approval Date : 2013-03-13
Application Number : 21038
Regulatory Info : RX
Registration Country : USA
