Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018227
Company: HOSPIRA
Company: HOSPIRA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMIDATE | ETOMIDATE | 2MG/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 |
|---|---|---|---|---|---|---|---|
| 09/07/1982 | ORIG-1 | Approval | Type 1 - New Molecular Entity | 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 |
|---|---|---|---|---|---|
| 04/27/2017 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018227s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/018227Orig1s032ltr.pdf | |
| 07/03/2002 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/03/2002 | SUPPL-16 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 04/06/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/29/1999 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/1999 | SUPPL-12 | Labeling |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/018227_s012_AmidateTOC.cfm |
| 09/29/1998 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/30/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1994 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/25/1988 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/16/1986 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/30/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/30/1985 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/15/1986 | 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 |
|---|---|---|---|---|---|
| 04/27/2017 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/018227s032lbl.pdf |
AMIDATE
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 |