01 7Orion Corporation
02 2Ethypharm
03 1Ever Pharma
04 3Accord healthcare
05 1Actavis Inc
06 1American Regent
07 4Amneal Pharmaceuticals
08 1Auro Pharma Inc
09 3Aurobindo Pharma Limited
10 3Baxter Healthcare Corporation
11 2BioXcel Therapeutics
12 2DECHRA VETERINARY PRODUCTS INC.
13 1Darou Darman Arang
14 1Dong Bang Co., Ltd
15 3ENDO OPERATIONS
16 1EUGIA PHARMA INC.
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 2MODERN VETERINARY THERAPEUTICS LLC
28 1Meitheal Pharmaceuticals
29 2Milla Pharmaceuticals
30 3Pfizer Inc
31 1Piramal Enterprises Limited
32 1Polifarma
33 1Rising Pharmaceuticals Inc
34 1Sandoz B2B
35 2Somerset Pharmaceuticals Inc
36 3Tagi Pharma
37 2Teva Pharmaceutical Industries
38 3Viatris
39 3WILSHIRE PHARMS INC
40 1Yichang Humanwell Pharmaceutical
41 1Zydus Pharmaceuticals
42 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 1INF
08 1INJ
09 52INJECTABLE;INJECTION
10 1INJECTION
11 1Inj
12 1Injectable
13 2Injectable Solution
14 4Injection
15 16SOLUTION
16 6SOLUTION;INTRAVENOUS
17 1Solution for Infusion
18 1Vial
01 3DISCN
02 3Generic
03 1Originator
04 56RX
05 2US ANDA- Submitted
06 32Blank
01 1Aro-midin
02 1CEPETOR
03 1DEMETEV
04 1DEXDOMITOR
05 1DEXMEDESED
06 53DEXMEDETOMIDINE HYDROCHLORIDE
07 3DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION
08 2DEXMEDETOMIDINE HYDROCHLORIDE FOR INJECTION, USP
09 3DEXMEDETOMIDINE HYDROCHLORIDE INJECTION
10 1DEXVETIDINE
11 5Dexdor
12 2IGALMI
13 1Medetin
14 7PRECEDEX
15 1Precedex
16 1SEDAJECT
17 1SILEO
18 1Sedalpha
19 1ZENALPHA
20 10Blank
01 1Austria
02 2Brazil
03 17Canada
04 3China
05 2France
06 1Iran
07 1Latvia
08 4Norway
09 3South Africa
10 1South Korea
11 1Sweden
12 1Turkey
13 60USA
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 : 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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