01 1Aspen Pharmacare Holdings
02 10Orion Corporation
03 2Ethypharm
04 4Ever 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 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 1Deva Holding AS
20 1Dong Bang Co., Ltd
21 1EQL Pharma
22 1Eugia Pharma
23 1Eurofarma Laboratorios S.A
24 1Farmak JSC
25 1Forrester Pharma
26 3Fresenius Kabi AB Brunna
27 3Fresenius Kabi AG
28 5Fresenius Kabi USA
29 3GLAND PHARMA LIMITED
30 1Grey Wolf Animal Health
31 4HQ SPCLT PHARMA
32 8Hikma Pharmaceuticals
33 5Hospira, Inc.
34 6Jiangsu Hengrui Medicine
35 4Juno Pharmaceuticals Pty Ltd
36 4Kalcex
37 1LABORATORIOS NORMON SA
38 3Labatec Pharm
39 1Lorien Laboratories Sl
40 2MODERN VETERINARY THERAPEUTICS LLC
41 1Meitheal Pharmaceuticals
42 2Milla Pharmaceuticals
43 1Montage Laboratories
44 3Orion Pharma
45 3PH HEALTH
46 3Pfizer Inc
47 1Pharmacorp
48 1Piramal Enterprises Limited
49 1Polifarma
50 2Recipharm AB
51 1Rising Pharmaceuticals Inc
52 1Sandoz B2B
53 2Somerset Pharmaceuticals Inc
54 1Sun Pharmaceutical Industries Limited
55 3Tagi Pharma
56 3Teva Pharmaceutical Industries
57 3Themis Medicare
58 5Viatris
59 3WILSHIRE PHARMS INC
60 1Yichang Humanwell Pharmaceutical
61 1Yuria-Pharm
62 1Zydus Pharmaceuticals
63 1Blank
01 1Concentated Solution For IV Infusion
02 5Concentrate For Infusion Solution
03 36Concentrate 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 26Blank
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 1Dexanest
14 8Dexdor
15 1Dexdor 1000ugml
16 1Dexdor 200ugml
17 1Dexdor 400ugml
18 1Dexem 0.5
19 1Dexem 1
20 1Dexem 2
21 1Dexmedetomidin Fresenius iv 200ugml
22 1Dexmedetomidina Accord
23 2Dexmedetomidina Altan
24 3Dexmedetomidina B. Braun
25 1Dexmedetomidina Baxter
26 1Dexmedetomidina Ever Pharma
27 3Dexmedetomidina Hikma
28 1Dexmedetomidina Kabi
29 1Dexmedetomidina Kalceks
30 1Dexmedetomidina Lorien
31 1Dexmedetomidina Normon
32 1Dexmedetomidina Rph Pharma
33 2Dexmedetomidine
34 2Dexmedetomidine Accord
35 1Dexmedetomidine Altan
36 1Dexmedetomidine Altan Pharma
37 3Dexmedetomidine B. Braun
38 1Dexmedetomidine Baxter
39 1Dexmedetomidine Baxter ?g
40 1Dexmedetomidine Eql Pharma
41 1Dexmedetomidine Ever Pharma
42 1Dexmedetomidine Ever Valinject
43 1Dexmedetomidine Fresenius iv 1000ugml
44 1Dexmedetomidine Fresenius iv 400ugml
45 1Dexmedetomidine Hydrochloride
46 2Dexmedetomidine Kabi
47 3Dexmedetomidine Kalceks
48 3Dexmedetomidine Labatec ?g
49 1Dexmedetomidine Rph Pharma
50 1Dexmedetomidine Teva
51 1Dexmedetomidine Viatris
52 1Eccladex
53 2IGALMI
54 1Kvanadex
55 1Medetin
56 7PRECEDEX
57 1Precedex
58 1Precia
59 1Prexodin
60 1SEDAJECT
61 1SILEO
62 1Sedalpha 100 µg/ml
63 1Sedmedex 100 µg/ml
64 1TOMEXA 200 μg/2 ml
65 1ZENALPHA
66 9Blank
01 1Austria
02 2Brazil
03 17Canada
04 3China
05 2France
06 6India
07 1Iran
08 2Malta
09 6Moldova
10 4Norway
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 :
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 : 100MCG
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
