01 1Aspen Pharmacare Holdings
02 7Orion Corporation
03 2Ethypharm
04 1Ever Pharma
05 3Accord healthcare
06 1Actavis Inc
07 1American Regent
08 4Amneal Pharmaceuticals
09 1Auro Pharma Inc
10 3Aurobindo Pharma Limited
11 3Baxter Healthcare Corporation
12 2BioXcel Therapeutics
13 2Cuckos
14 2DECHRA VETERINARY PRODUCTS INC.
15 1Darou Darman Arang
16 1Dong Bang Co., Ltd
17 1EUGIA PHARMA INC.
18 3Endo International
19 1Eurofarma Laboratorios S.A
20 5Fresenius Kabi USA
21 3GLAND PHARMA LIMITED
22 1Grey Wolf Animal Health
23 1Grindeks AS
24 4HQ SPCLT PHARMA
25 5Hikma Pharmaceuticals
26 5Hospira, Inc.
27 3JUNO PHARMACEUTICALS CORP.
28 6Jiangsu Hengrui Medicine
29 1Juno Pharma SA (Pty) Ltd
30 1Lamar International (Pty) Ltd
31 2MODERN VETERINARY THERAPEUTICS LLC
32 1Meitheal Pharmaceuticals
33 2Milla Pharmaceuticals
34 1Montage Laboratories
35 3Pfizer Inc
36 1Pharmacorp (Pty) Ltd
37 1Piramal Enterprises Limited
38 1Polifarma
39 1Rising Pharmaceuticals Inc
40 1Sandoz B2B
41 2Somerset Pharmaceuticals Inc
42 1Sun Pharmaceutical Industries Limited
43 3Tagi Pharma
44 2Teva Pharmaceutical Industries
45 3Themis Medicare
46 4Viatris
47 3WILSHIRE PHARMS INC
48 1Yichang Humanwell Pharmaceutical
49 1Zydus Pharmaceuticals
50 1Blank
01 1CONCENTRATE FOR SOLUTION FOR INFUSION
02 1Concentated Solution For IV Infusion
03 1Concentrate for Solution for Infusion
04 4Concentrate to the infusion fluid, resolution
05 2FILM;BUCCAL, SUBLINGUAL
06 1GEL
07 3INF
08 6INJ
09 53INJECTABLE;INJECTION
10 1INJECTION
11 1Injectable
12 2Injectable Solution
13 9Injection
14 1Liquid Injection
15 16SOLUTION
16 6SOLUTION;INTRAVENOUS
17 1Solution for Infusion
18 1Vial
01 3DISCN
02 9Generic
03 1Originator
04 57RX
05 2US ANDA- Submitted
06 38Blank
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 5Dexdor
14 1Dexem 0.5
15 1Dexem 1
16 1Dexem 2
17 2Dexmedetomidine
18 1Dexmedetomidine Hydrochloride
19 1Eccladex
20 2IGALMI
21 1Medetin
22 7PRECEDEX
23 1Precedex
24 1Precia
25 1SEDAJECT
26 1SILEO
27 1Sedalpha 100 µg/ml
28 1Sedmedex 100 µg/ml
29 1TOMEXA 200 μg/2 ml
30 1ZENALPHA
31 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 1Sweden
13 1Turkey
14 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 : Sweden
Brand Name : Dexdor
Dosage Form : CONCENTRATE FOR SOLUTION FOR INFUSION
Dosage Strength : 100 MICROGRAM / ML
Packaging :
Approval Date :
Application Number :
Regulatory Info :
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 : 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 : Ampoule
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 : 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 :
Registration Country : Canada
Brand Name : DEXDOMITOR
Dosage Form : SOLUTION
Dosage Strength : 0.5MG/ML
Packaging : 10ML
Approval Date :
Application Number : 2333929
Regulatory Info :
Registration Country : Canada
Regulatory Info :
Registration Country : Canada
Brand Name : SILEO
Dosage Form : GEL
Dosage Strength : 0.1MG/ML
Packaging :
Approval Date :
Application Number : 2530392
Regulatory Info :
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
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 : 2015-09-18
Application Number : 201072
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 : 2015-08-20
Application Number : 202126
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
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 : 2014-11-24
Application Number : 202585
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
