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Drugs@FDA: FDA-Approved Drugs

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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
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription None Yes Yes
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
08/12/2022 SUPPL-33 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021038s031s033lbl.pdf
08/12/2022 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021038s031s033lbl.pdf
01/31/2020 SUPPL-35 Manufacturing (CMC)-Facility Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021038s035lbl.pdf
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
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