01 1Aspen Pharmacare Holdings
02 6Orion 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 2DECHRA VETERINARY PRODUCTS INC.
14 1Darou Darman Arang
15 1Dong Bang Co., Ltd
16 3ENDO OPERATIONS
17 1Eurofarma Laboratorios S.A
18 5Fresenius Kabi USA
19 3GLAND PHARMA LIMITED
20 1Grey Wolf Animal Health
21 1Grindeks AS
22 4HQ SPCLT PHARMA
23 4Hikma Pharmaceuticals
24 5Hospira, Inc.
25 3JUNO PHARMACEUTICALS CORP.
26 6Jiangsu Hengrui Medicine
27 1Kahma Group
28 1Lamar International (Pty) Ltd
29 2MODERN VETERINARY THERAPEUTICS LLC
30 1Meitheal Pharmaceuticals
31 2Milla Pharmaceuticals
32 3Pfizer Inc
33 1Piramal Enterprises Limited
34 1Polifarma
35 1RANBAXY LABORATORIES LIMITED
36 1Rising Pharmaceuticals Inc
37 1Sandoz B2B
38 2Somerset Pharmaceuticals Inc
39 3Tagi Pharma
40 2Teva Pharmaceutical Industries
41 4Viatris
42 3WILSHIRE PHARMS INC
43 1Yichang Humanwell Pharmaceutical
44 1Zydus Pharmaceuticals
45 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 3INF
07 5INJ
08 52INJECTABLE;INJECTION
09 1INJECTION
10 1Injectable
11 2Injectable Solution
12 4Injection
13 15SOLUTION
14 6SOLUTION;INTRAVENOUS
15 1Solution for Infusion
16 1Vial
01 3DISCN
02 8Generic
03 1Originator
04 15Prescription
05 56RX
06 2US ANDA- Submitted
07 15Blank
01 1Aro-midin
02 1CEPETOR
03 1DEMETEV
04 1DEXDOMITOR
05 1DEXISUN
06 1DEXMEDESED
07 53DEXMEDETOMIDINE HYDROCHLORIDE
08 2DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
09 2DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP
10 3DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
11 1DEXVETIDINE
12 1Demodinex
13 5Dexdor
14 1Eccladex
15 2IGALMI
16 1Medetin
17 7PRECEDEX
18 1Precedex
19 1Precia
20 1SEDAJECT
21 1Sedalpha 100 µg/ml
22 1Sedmedex 100 µg/ml
23 1ZENALPHA
24 10Blank
01 1Austria
02 2Brazil
03 15Canada
04 3China
05 2France
06 1Iran
07 1Latvia
08 4Norway
09 8South Africa
10 1South Korea
11 1Sweden
12 1Turkey
13 60USA
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.
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 : 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
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 : 2016-02-09
Application Number : 204023
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 : 2016-10-17
Application Number : 204686
Regulatory Info : RX
Registration Country : USA
Regulatory Info : DISCN
Registration Country : USA
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Packaging :
Approval Date : 2017-05-12
Application Number : 203773
Regulatory Info : DISCN
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 : 2016-03-17
Application Number : 205867
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 : 2015-09-18
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 : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
Packaging :
Approval Date : 2017-04-26
Application Number : 205046
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/50ML (EQ 4MCG BASE/ML)
Packaging :
Approval Date : 2020-01-30
Application Number : 206407
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : DEXMEDETOMIDINE HYDROCHLORIDE
Dosage Form : INJECTABLE;INJECTION
Dosage Strength : EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Packaging :
Approval Date : 2020-01-30
Application Number : 206407
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 : 2019-01-18
Application Number : 204843
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
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 : 2017-11-28
Application Number : 205272
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 : 2014-08-18
Application Number : 202881
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 : 2014-08-18
Application Number : 203972
Regulatory Info : RX
Registration Country : USA
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