Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 202881
Company: MYLAN INSTITUTIONAL
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription AP No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
08/18/2014 ORIG-1 Approval

Label is not available on this site.

DEXMEDETOMIDINE HYDROCHLORIDE

INJECTABLE;INJECTION; EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML)
TE Code = AP

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 204023 ACCORD HLTHCARE
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 204686 ACTAVIS INC
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 202585 AKORN INC
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 205867 AUROBINDO PHARMA LTD
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 201072 FRESENIUS KABI USA
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209065 JIANGSU HENGRUI MED
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 202881 MYLAN INSTITUTIONAL
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 203972 PAR STERILE PRODUCTS
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 091465 SANDOZ INC
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 202126 SUN PHARM INDS INC
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 205272 TEVA PHARMS USA
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 205046 WEST-WARD PHARMS INT
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 206798 ZYDUS PHARMS
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 021038 HOSPIRA

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