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Home | Previous Page

New Drug Application (NDA): 021038
Company: HOSPIRA
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PRODUCTS ON NDA 021038

CSVExcelPrint

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
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

Showing 1 to 5 of 5 entries

APPROVAL DATE(S) AND HISTORY, LETTERS, LABELS, REVIEWS FOR NDA 021038

ORIGINAL APPROVALS OR TENTATIVE APPROVALS

CSVExcelPrint

Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan
Status Letters, Reviews, Labels, Patient Package InsertNotes 12/17/1999 ORIG-1
Approval Type 1 - New Molecular Entity STANDARD Label (PDF)
Letter (PDF)
Review


Showing 1 to 1 of 1 entries

SUPPLEMENTS

CSVExcelPrint

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews,
Labels, Patient Package Insert Note 12/16/2022 SUPPL-28 Efficacy-Labeling Change
With Clinical Data Label (PDF)
Letter (PDF)
08/12/2022 SUPPL-33 Labeling-Package Insert Label (PDF)
Letter (PDF)
08/12/2022 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
01/31/2020 SUPPL-35 Manufacturing (CMC)-Facility Label (PDF)
Letter (PDF)
04/11/2016 SUPPL-27 Labeling-Package Insert Label (PDF)
Letter (PDF)
11/14/2014 SUPPL-26 Labeling-Container/Carton Labels, Labeling-Package Insert
Label (PDF)
Letter (PDF)
11/14/2014 SUPPL-24 Manufacturing (CMC) Label (PDF)
Letter (PDF)
11/14/2014 SUPPL-19 Labeling-Package Insert Label (PDF)
Letter (PDF)
04/18/2014 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

01/16/2014 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

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)
06/17/2013 SUPPL-21 Efficacy-Pediatric Label (PDF)
Letter (PDF)
03/13/2013 SUPPL-20 Manufacturing (CMC) Label (PDF)
Review (PDF)
10/13/2010 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
Review (PDF)
10/17/2008 SUPPL-10 Efficacy-New Indication Letter (PDF)


Label is not available on this site.

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.

Showing 1 to 18 of 18 entries

LABELS FOR NDA 021038

CSVExcelPrint

Action DateSubmissionSupplement Categories or Approval TypeLetters, Reviews,
Labels,
Patient Package InsertNote 12/16/2022 SUPPL-28 Efficacy-Labeling Change With
Clinical Data Label (PDF) 08/12/2022 SUPPL-33 Labeling-Package Insert Label
(PDF) 08/12/2022 SUPPL-31 Labeling-Package Insert Label (PDF) 01/31/2020
SUPPL-35 Manufacturing (CMC)-Facility Label (PDF) 04/11/2016 SUPPL-27
Labeling-Package Insert Label (PDF) 11/14/2014 SUPPL-26
Labeling-Container/Carton Labels Label (PDF) 11/14/2014 SUPPL-26
Labeling-Package Insert Label (PDF) 11/14/2014 SUPPL-24 Manufacturing (CMC)
Label (PDF) This supplement type does not usually require new labeling.
11/14/2014 SUPPL-19 Labeling-Package Insert Label (PDF) 06/17/2013 SUPPL-22
Efficacy-Pediatric Label (PDF) 06/17/2013 SUPPL-21 Efficacy-Pediatric Label
(PDF) 03/13/2013 SUPPL-20 Manufacturing (CMC) Label (PDF) This supplement type
does not usually require new labeling. 10/13/2010 SUPPL-17 Labeling-Package
Insert Label (PDF) 12/17/1999 ORIG-1 Approval Label (PDF)

Showing 1 to 14 of 14 entries

THERAPEUTIC EQUIVALENTS FOR NDA 021038

PRECEDEX



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

CSVExcelPrint

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE
CodeApplication 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 DEXMEDETOMIDINE
HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/2ML (EQ 100MCG
BASE/ML) INJECTABLE;INJECTION Prescription No AP 205867 EUGIA PHARMA
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 202126
GLAND DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG
BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209065
HENGRUI PHARMA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ
200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP
205046 HIKMA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ
200MCG BASE/2ML (EQ 100MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP
204843 MEITHEAL 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 205272 TEVA PHARMS USA
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

Showing 1 to 15 of 15 entries



INJECTABLE;INJECTION; EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
TE Code = AP

CSVExcelPrint

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE
CodeApplication No.Company DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE
HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription No AP 207551 AMNEAL PHARMS CO 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 210321 EUGIA PHARMA
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML
(EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208129 FRESENIUS KABI
USA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG
BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209307 GLAND
PHARMA LTD DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG
BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209065
HENGRUI PHARMA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ
200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP
206407 HIKMA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ
200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP
212571 MYLAN LABS LTD DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE
HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription No AP 208266 PAR STERILE PRODUCTS DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION Prescription No AP 212791 SLAYBACK PHARMA LLC
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML
(EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 212857 TAGI PRECEDEX
DEXMEDETOMIDINE HYDROCHLORIDE EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION Prescription Yes AP 021038 HOSPIRA

Showing 1 to 12 of 12 entries



INJECTABLE;INJECTION; EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
TE Code = AP

CSVExcelPrint

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE
CodeApplication No.Company DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE
HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription No AP 207551 AMNEAL PHARMS CO 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 210321 EUGIA PHARMA
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML
(EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 208129 FRESENIUS KABI
USA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG
BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 209307
GLAND PHARMA LTD DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ
400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP
209065 HENGRUI PHARMA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE
HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription No AP 206407 HIKMA DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE
HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription No AP 212571 MYLAN LABS LTD DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION Prescription No AP 208266 PAR STERILE PRODUCTS
DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML
(EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 212791 SLAYBACK PHARMA
LLC DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG
BASE/100ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION Prescription No AP 212857 TAGI
PRECEDEX DEXMEDETOMIDINE HYDROCHLORIDE EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION Prescription Yes AP 021038 HOSPIRA

Showing 1 to 12 of 12 entries



INJECTABLE;INJECTION; EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
TE Code = AP

CSVExcelPrint

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE
CodeApplication No.Company DEXMEDETOMIDINE HYDROCHLORIDE DEXMEDETOMIDINE
HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription No AP 208129 FRESENIUS KABI USA DEXMEDETOMIDINE HYDROCHLORIDE
DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION Prescription No AP 209065 HENGRUI PHARMA DEXMEDETOMIDINE
HYDROCHLORIDE DEXMEDETOMIDINE HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML)
INJECTABLE;INJECTION Prescription No AP 212857 TAGI PRECEDEX DEXMEDETOMIDINE
HYDROCHLORIDE EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) INJECTABLE;INJECTION
Prescription Yes AP 021038 HOSPIRA

Showing 1 to 4 of 4 entries




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