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 | 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.html |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/01/2026 | SUPPL-61 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021038s061lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/021038Orig1s061ltr.pdf | |
| 10/11/2024 | SUPPL-55 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021038Orig1s055lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021038Orig1s055ltr.pdf | |
| 01/31/2020 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021038s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021038Orig1s035ltr.pdf | |
| 08/12/2022 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021038s031s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021038Orig1s031, s033ltr.pdf | |
| 08/12/2022 | SUPPL-31 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021038s031s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021038Orig1s031, s033ltr.pdf | |
| 12/16/2022 | SUPPL-28 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/021038s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/021038Orig1s028ltr.pdf | |
| 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-Container/Carton Labels, 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 | |
| 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 |
|---|---|---|---|---|---|
| 05/01/2026 | SUPPL-61 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/021038s061lbl.pdf | |
| 10/11/2024 | SUPPL-55 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021038Orig1s055lbl.pdf | |
| 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.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-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 | 208103 | BAXTER HLTHCARE CORP |
| 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 | 218675 | KNACK |
| 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 | PH HEALTH |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 202585 | RISING |
| 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 |
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 | 216604 | AMNEAL |
| 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 | 220315 | DR REDDYS |
| 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 |
| 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 | 217308 | MILLA PHARMS |
| 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 | PH HEALTH |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212857 | TAGI |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212791 | WILSHIRE PHARMS INC |
| 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 | 216604 | AMNEAL |
| 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 | 220315 | DR REDDYS |
| 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 |
| 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 | 217308 | MILLA PHARMS |
| 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 | PH HEALTH |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212857 | TAGI |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 212791 | WILSHIRE PHARMS INC |
| 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 |
| 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 |
INJECTABLE;INJECTION; EQ 1MG BASE/250ML (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 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 206407 | HIKMA |
| PRECEDEX | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 1MG BASE/250ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | Yes | AP | 021038 | HOSPIRA |