Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209065
Company: HENGRUI PHARMA
Company: HENGRUI PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 80MCG BASE/20ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 09/19/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/29/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
DEXMEDETOMIDINE HYDROCHLORIDE
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 | 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 | 202585 | RISING |
| DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | INJECTABLE;INJECTION | Prescription | No | AP | 091465 | SANDOZ |
| 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 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 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 | 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 | 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 | 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 |
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 | 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 | 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 | 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 |