01 1Aspen Pharmacare Holdings
02 6Orion Corporation
03 2Ethypharm
04 5Ever Pharma
05 6Accord healthcare
06 1Actavis Inc
07 4Altan Pharma
08 1American Regent
09 4Amneal Pharmaceuticals
10 1Auro Pharma Inc
11 3Aurobindo Pharma Limited
12 9B. Braun Melsungen AG
13 3Baxter Healthcare Corporation
14 3Bayer AG
15 2BioXcel Therapeutics
16 2CP Pharm
17 2Cuckos
18 2DECHRA VETERINARY PRODUCTS AS
19 1Darou Darman Arang
20 1Deva Holding AS
21 1Dong Bang Co., Ltd
22 1EQL Pharma
23 1EUROVET ANIMAL HEALTH B.V.
24 1Eugia Pharma
25 1Eurofarma Laboratorios S.A
26 1Farmak JSC
27 1Forrester Pharma
28 3Fresenius Kabi AB Brunna
29 3Fresenius Kabi AG
30 5Fresenius Kabi USA
31 3GLAND PHARMA LIMITED
32 1Grey Wolf Animal Health
33 4HQ SPCLT PHARMA
34 8Hikma Pharmaceuticals
35 5Hospira, Inc.
36 6Jiangsu Hengrui Medicine
37 4Juno Pharmaceuticals Pty Ltd
38 8Kalcex
39 1LABORATORIOS NORMON SA
40 3Labatec Pharm
41 1Laboratorios SYVA SAU
42 1Le Vet Beheer BV
43 1Lorien Laboratories Sl
44 2MODERN VETERINARY THERAPEUTICS LLC
45 1Meitheal Pharmaceuticals
46 2Milla Pharmaceuticals
47 1Montage Laboratories
48 1ORIFARM GROUP AS
49 3Orion Pharma
50 3PH HEALTH
51 3Pfizer Inc
52 1Pharmacorp
53 1Piramal Enterprises Limited
54 1Polifarma
55 2Recipharm AB
56 1Rising Pharmaceuticals Inc
57 1Sandoz B2B
58 2Somerset Pharmaceuticals Inc
59 1Sun Pharmaceutical Industries Limited
60 3Tagi Pharma
61 3Teva Pharmaceutical Industries
62 3Themis Medicare
63 1Vetcare OY
64 1Vetpharma
65 5Viatris
66 3WILSHIRE PHARMS INC
67 1Yichang Humanwell Pharmaceutical
68 1Yuria-Pharm
69 1Zydus Pharmaceuticals
70 1Blank
01 1Concentated Solution For IV Infusion
02 5Concentrate For Infusion Solution
03 44Concentrate For Solution For Infusion
04 1Concentrate for Solution for Infusion
05 2FILM;BUCCAL, SUBLINGUAL
06 1GEL
07 3INF
08 6INJ
09 53INJECTABLE;INJECTION
10 3Infusion Solution
11 1Injectable
12 2Injectable Solution
13 9Injection
14 1Liquid Injection
15 16SOLUTION
16 6SOLUTION;INTRAVENOUS
17 2Solution For Infusion
18 11Solution For Injection
19 3Solution For Perfusion
20 1Solution for Infusion
21 1Vial
01 10Allowed
02 12Approved
03 2Authorised
04 18Authorized
05 1Cancelled
06 3DISCN
07 3Deregistered
08 8Generic
09 13Marketed
10 3Not Marketed
11 1Originator
12 17Prescription
13 57RX
14 2US ANDA- Submitted
15 22Blank
01 1Aro-midin
02 1CEPETOR
03 1Cepedex
04 1Cepetor knows
05 1DEMETEV
06 1DEXDOMITOR
07 1DEXISUN
08 1DEXMEDESED
09 54DEXMEDETOMIDINE HYDROCHLORIDE
10 3DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
11 2DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP
12 3DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
13 1DEXVETIDINE
14 1Demodinex
15 1Dexanest
16 1Dexdomitor
17 4Dexdor
18 1Dexdor 1000ugml
19 1Dexdor 200ugml
20 1Dexdor 400ugml
21 1Dexem 0.5
22 1Dexem 1
23 1Dexem 2
24 1Dexmedetomidin Fresenius iv 200ugml
25 1Dexmedetomidina Accord
26 2Dexmedetomidina Altan
27 3Dexmedetomidina B. Braun
28 1Dexmedetomidina Baxter
29 1Dexmedetomidina Ever Pharma
30 3Dexmedetomidina Hikma
31 1Dexmedetomidina Kabi
32 1Dexmedetomidina Kalceks
33 1Dexmedetomidina Lorien
34 1Dexmedetomidina Normon
35 1Dexmedetomidina Rph Pharma
36 2Dexmedetomidine
37 2Dexmedetomidine Accord
38 1Dexmedetomidine Altan
39 1Dexmedetomidine Altan Pharma
40 6Dexmedetomidine B. Braun
41 1Dexmedetomidine Baxter
42 1Dexmedetomidine Baxter ?g
43 1Dexmedetomidine Eql Pharma
44 2Dexmedetomidine Ever Pharma
45 1Dexmedetomidine Ever Valinject
46 1Dexmedetomidine Fresenius iv 1000ugml
47 1Dexmedetomidine Fresenius iv 400ugml
48 1Dexmedetomidine Hydrochloride
49 2Dexmedetomidine Kabi
50 7Dexmedetomidine Kalceks
51 3Dexmedetomidine Labatec ?g
52 1Dexmedetomidine Rph Pharma
53 1Dexmedetomidine Teva
54 1Dexmedetomidine Viatris
55 1Dexmopet vet
56 1Eccladex
57 2IGALMI
58 1Kvanadex
59 1Medetin
60 1Medodin knows
61 7PRECEDEX
62 1Precedex
63 1Precia
64 1Prexodin
65 1SEDAJECT
66 1SILEO
67 1Sedadex
68 1Sedalpha 100 µg/ml
69 1Sedmedex 100 µg/ml
70 1TOMEXA 200 μg/2 ml
71 1The Dorbene knows
72 1ZENALPHA
73 1Zenalpha
74 9Blank
01 1Austria
02 2Brazil
03 17Canada
04 3China
05 2France
06 6India
07 1Iran
08 2Malta
09 6Moldova
10 16Norway
11 9South Africa
12 1South Korea
13 19Spain
14 15Sweden
15 10Switzerland
16 1Turkey
17 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 : 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
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 : 100MCG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Austria
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
Ever Pharma, highly specialized CDMO in producing complex injectables including high potency & controlled substances, suspensions, etc.
Regulatory Info : Marketed
Registration Country : Norway
Brand Name : Dexmedetomidine Ever Pharma
Dosage Form : Concentrate For Solution For Infusion
Dosage Strength : 100mcg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info : Marketed
Registration Country : Norway
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
Regulatory Info : RX
Registration Country : USA
Brand Name : PRECEDEX
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
Packaging :
Approval Date : 2014-11-14
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 1MG BASE/250ML (EQ 4MCG BASE/ML)
Packaging :
Approval Date : 2020-01-31
Application Number : 21038
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Packaging :
Approval Date : 2016-06-14
Application Number : 91465
Regulatory Info : RX
Registration Country : USA
