Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 201044
Company: MYLAN LABS LTD
Company: MYLAN LABS LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETOMIDATE | ETOMIDATE | 2MG/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 |
|---|---|---|---|---|---|---|---|
| 02/07/2017 | ORIG-1 | Approval | Not Applicable |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/07/2018 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
ETOMIDATE
INJECTABLE;INJECTION; 2MG/ML
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 018227 | HOSPIRA |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 215028 | CAPLIN |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 206126 | EUGIA PHARMA |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 209058 | GLAND PHARMA LTD |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 074593 | HIKMA |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202354 | HIKMA |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 201044 | MYLAN LABS LTD |
| ETOMIDATE | ETOMIDATE | 2MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202360 | ZYDUS PHARMS |