Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021038
Company: HOSPIRA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription AP Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
12/17/1999 ORIG-1 Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21038ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-038_Precedex.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/11/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021038s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021038Orig1s027ltr.pdf
11/14/2014 SUPPL-26 Labeling-Package Insert, Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf
01/16/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

11/14/2014 SUPPL-24 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf
09/28/2013 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

06/17/2013 SUPPL-22 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022ltr.pdf
06/17/2013 SUPPL-21 Efficacy-Pediatric Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022ltr.pdf
03/13/2013 SUPPL-20 Manufacturing (CMC) Label (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021038Orig1s020.pdf
11/14/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf
10/13/2010 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021038s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021038s017ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021038Orig1s017.pdf
04/18/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/17/2008 SUPPL-10 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021038s010ltr.pdf
05/08/2001 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/2001 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/11/2016 SUPPL-27 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021038s027lbl.pdf
11/14/2014 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf
11/14/2014 SUPPL-26 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf
11/14/2014 SUPPL-24 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf
11/14/2014 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf
06/17/2013 SUPPL-22 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s022lbl.pdf
06/17/2013 SUPPL-21 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s021lbl.pdf
03/13/2013 SUPPL-20 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s020lbl.pdf
10/13/2010 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021038s017lbl.pdf
12/17/1999 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21038lbl.pdf

PRECEDEX

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

INJECTABLE;INJECTION; EQ 200MCG BASE/50ML (EQ 4MCG 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/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208532 BAXTER HLTHCARE CORP
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208129 FRESENIUS KABI USA
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 021038 HOSPIRA

INJECTABLE;INJECTION; EQ 400MCG BASE/100ML (EQ 4MCG 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 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208532 BAXTER HLTHCARE CORP
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208129 FRESENIUS KABI USA
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 021038 HOSPIRA

INJECTABLE;INJECTION; EQ 80MCG BASE/20ML (EQ 4MCG 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 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208129 FRESENIUS KABI USA
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription Yes AP 021038 HOSPIRA

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