01 1Aspen Pharmacare Holdings
02 6Orion Corporation
03 2Ethypharm
04 5Ever Pharma
05 7Accord healthcare
06 1Actavis Inc
07 4Altan Pharma
08 1American Regent
09 4Amneal Pharmaceuticals
10 1Auro Pharma Inc
11 3Aurobindo Pharma Limited
12 1Auxilia Pharma Oü
13 9B. Braun Melsungen AG
14 3Baxter Healthcare Corporation
15 3Bayer AG
16 2BioXcel Therapeutics
17 2CP Pharm
18 1Caplin Point Laboratories Limited
19 2Cuckos
20 2DECHRA VETERINARY PRODUCTS AS
21 1Darou Darman Arang
22 1Deva Holding AS
23 1Dong Bang Co., Ltd
24 1EQL Pharma
25 1EUROVET ANIMAL HEALTH B.V.
26 1Eugia Pharma
27 1Eurofarma Laboratorios S.A
28 1Farmak JSC
29 1Forrester Pharma
30 4Fresenius Kabi AB Brunna
31 3Fresenius Kabi AG
32 5Fresenius Kabi USA
33 3GLAND PHARMA LIMITED
34 1Grey Wolf Animal Health
35 4HQ SPCLT PHARMA
36 8Hikma Pharmaceuticals
37 5Hospira, Inc.
38 1Ideal Trade Links Uab
39 6Jiangsu Hengrui Medicine
40 4Juno Pharmaceuticals Pty Ltd
41 9Kalcex
42 1LABORATORIOS NORMON SA
43 3Labatec Pharm
44 1Laboratorios SYVA SAU
45 1Le Vet Beheer BV
46 1Lorien Laboratories Sl
47 2MODERN VETERINARY THERAPEUTICS LLC
48 1Meitheal Pharmaceuticals
49 2Milla Pharmaceuticals
50 1Montage Laboratories
51 1ORIFARM GROUP AS
52 3Orion Pharma
53 3PH HEALTH
54 2Pfizer Inc
55 1Pharmacorp
56 1Piramal Enterprises Limited
57 1Polifarma
58 2Recipharm AB
59 1Rising Pharmaceuticals Inc
60 2Somerset Pharmaceuticals Inc
61 1Sun Pharmaceutical Industries Limited
62 3Tagi Pharma
63 3Teva Pharmaceutical Industries
64 3Themis Medicare
65 1Vetcare OY
66 1Vetpharma
67 5Viatris
68 3WILSHIRE PHARMS INC
69 1Yichang Humanwell Pharmaceutical
70 1Yuria-Pharm
71 1Zydus Pharmaceuticals
72 1Blank
01 1Concentated Solution For IV Infusion
02 5Concentrate For Infusion Solution
03 49Concentrate 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 15SOLUTION
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 21Prescription
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 3Dexmedetomidine Accord
38 1Dexmedetomidine Altan
39 1Dexmedetomidine Altan Pharma
40 1Dexmedetomidine Auxilia
41 6Dexmedetomidine B. Braun
42 1Dexmedetomidine Baxter
43 1Dexmedetomidine Baxter ?g
44 1Dexmedetomidine Eql Pharma
45 2Dexmedetomidine Ever Pharma
46 1Dexmedetomidine Ever Valinject
47 1Dexmedetomidine Fresenius iv 1000ugml
48 1Dexmedetomidine Fresenius iv 400ugml
49 1Dexmedetomidine Hydrochloride
50 3Dexmedetomidine Kabi
51 9Dexmedetomidine Kalceks
52 3Dexmedetomidine Labatec ?g
53 1Dexmedetomidine Rph Pharma
54 1Dexmedetomidine Teva
55 1Dexmedetomidine Viatris
56 1Dexmopet vet
57 1Eccladex
58 2IGALMI
59 1Kvanadex
60 1Medetin
61 1Medodin knows
62 6PRECEDEX
63 1Precedex
64 1Precia
65 1Prexodin
66 1SEDAJECT
67 1SILEO
68 1Sedadex
69 1Sedalpha 100 µg/ml
70 1Sedmedex 100 µg/ml
71 1TOMEXA 200 μg/2 ml
72 1The Dorbene knows
73 1ZENALPHA
74 1Zenalpha
75 9Blank
01 1Austria
02 2Brazil
03 16Canada
04 3China
05 5Estonia
06 2France
07 6India
08 1Iran
09 2Malta
10 6Moldova
11 16Norway
12 9South Africa
13 1South Korea
14 19Spain
15 15Sweden
16 10Switzerland
17 1Turkey
18 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 : 17-09-2018
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 : 10-11-2011
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 : 10-11-2011
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 : 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
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 : 22-03-2018
Application Number : 82586
Regulatory Info : Authorized
Registration Country : Spain
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
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
