Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206223
Company: FRESENIUS KABI USA
Company: FRESENIUS KABI USA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 2MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | AP | No | No |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 5MG BASE/VIAL | 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 |
|---|---|---|---|---|---|---|---|
| 01/16/2018 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206223Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/15/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/15/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
REMIFENTANIL HYDROCHLORIDE
INJECTABLE;INJECTION; EQ 1MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206223 | FRESENIUS KABI USA |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210594 | HIKMA |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215635 | NIVAGEN PHARMS INC |
| ULTIVA | REMIFENTANIL HYDROCHLORIDE | EQ 1MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020630 | MYLAN INSTITUTIONAL |
INJECTABLE;INJECTION; EQ 2MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 2MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206223 | FRESENIUS KABI USA |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 2MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210594 | HIKMA |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 2MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215635 | NIVAGEN PHARMS INC |
| ULTIVA | REMIFENTANIL HYDROCHLORIDE | EQ 2MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020630 | MYLAN INSTITUTIONAL |
INJECTABLE;INJECTION; EQ 5MG BASE/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 206223 | FRESENIUS KABI USA |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 210594 | HIKMA |
| REMIFENTANIL HYDROCHLORIDE | REMIFENTANIL HYDROCHLORIDE | EQ 5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | No | AP | 215635 | NIVAGEN PHARMS INC |
| ULTIVA | REMIFENTANIL HYDROCHLORIDE | EQ 5MG BASE/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020630 | MYLAN INSTITUTIONAL |