Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021038
Company: HOSPIRA
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 |
|---|---|---|---|---|---|
| 12/16/2022 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021038s028lbl.pdf | |
| 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 |