01 1Aspen Pharmacare Holdings
02 10Orion Corporation
03 2Ethypharm
04 3Ever 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 INC.
18 1Darou Darman Arang
19 1Dong Bang Co., Ltd
20 1EQL Pharma
21 1EUGIA PHARMA INC.
22 1Eurofarma Laboratorios S.A
23 2Fresenius Kabi AB Brunna
24 3Fresenius Kabi AG
25 5Fresenius Kabi USA
26 3GLAND PHARMA LIMITED
27 1Grey Wolf Animal Health
28 1Grindeks AS
29 4HQ SPCLT PHARMA
30 8Hikma Pharmaceuticals
31 5Hospira, Inc.
32 3JUNO PHARMACEUTICALS CORP.
33 6Jiangsu Hengrui Medicine
34 1Juno Pharma SA (Pty) Ltd
35 2Kalcex
36 1LABORATORIOS NORMON SA
37 3Labatec Pharm
38 1Lamar International (Pty) Ltd
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 (Pty) Ltd
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 4Viatris
59 1Viatris South Africa (Pty) Ltd
60 3WILSHIRE PHARMS INC
61 1Yichang Humanwell Pharmaceutical
62 1Zydus Pharmaceuticals
63 1Blank
01 1Concentated Solution For IV Infusion
02 5Concentrate For Infusion Solution
03 28Concentrate 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 1INJECTION
12 3Infusion Solution
13 1Injectable
14 2Injectable Solution
15 9Injection
16 1Liquid Injection
17 16SOLUTION
18 6SOLUTION;INTRAVENOUS
19 2Solution For Infusion
20 3Solution For Injection
21 3Solution For Perfusion
22 1Solution for Infusion
23 1Vial
01 10Allowed
02 12Approved
03 18Authorized
04 1Cancelled
05 3DISCN
06 3Deregistered
07 9Generic
08 1Originator
09 17Prescription
10 57RX
11 2US ANDA- Submitted
12 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 Fresenius iv 1000ugml
42 1Dexmedetomidine Fresenius iv 400ugml
43 1Dexmedetomidine Hydrochloride
44 1Dexmedetomidine Kabi
45 1Dexmedetomidine Kalceks
46 3Dexmedetomidine Labatec ?g
47 1Dexmedetomidine Rph Pharma
48 1Dexmedetomidine Teva
49 1Dexmedetomidine Viatris
50 1Eccladex
51 2IGALMI
52 1Medetin
53 7PRECEDEX
54 1Precedex
55 1Precia
56 1SEDAJECT
57 1SILEO
58 1Sedalpha 100 µg/ml
59 1Sedmedex 100 µg/ml
60 1TOMEXA 200 μg/2 ml
61 1ZENALPHA
62 10Blank
01 1Austria
02 2Brazil
03 17Canada
04 3China
05 2France
06 6India
07 1Iran
08 1Latvia
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
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
