Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020221
Company: CLINIGEN
Company: CLINIGEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ETHYOL | AMIFOSTINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | AP | Yes | Yes |
| ETHYOL | AMIFOSTINE | 375MG/VIAL | INJECTABLE;INJECTION | Discontinued | None | 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 |
|---|---|---|---|---|---|---|---|
| 12/08/1995 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020221Orig1s000rev.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/25/2019 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020221s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020221Orig1s036ltr.pdf | |
| 05/25/2017 | SUPPL-33 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020221s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020221Orig1s033ltr.pdf | |
| 12/15/2016 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020221s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020221Orig1s032ltr.pdf | |
| 01/15/2016 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2016 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/26/2013 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/2008 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020221s024ltr.pdf | |
| 03/28/2006 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020221s020ltr.pdf |
| 03/27/2003 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20221slr017ltr.pdf | |
| 02/20/2002 | SUPPL-15 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20221s15ltr.pdf |
| 09/10/1999 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1999 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/24/1999 | SUPPL-12 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20221s12ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20221-S012_Ethyol.cfm | |
| 02/11/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/11/1999 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 10/10/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/20/1997 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/18/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1996 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/15/1996 | SUPPL-2 | Efficacy-New Indication |
Label is not available on this site. |
||
| 01/23/1996 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 07/25/2019 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020221s036lbl.pdf | |
| 05/25/2017 | SUPPL-33 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020221s033lbl.pdf | |
| 12/15/2016 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020221s032lbl.pdf | |
| 11/07/2008 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf | |
| 03/27/2003 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf | |
| 06/24/1999 | SUPPL-12 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf |
ETHYOL
INJECTABLE;INJECTION; 500MG/VIAL
TE Code = AP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ETHYOL | AMIFOSTINE | 500MG/VIAL | INJECTABLE;INJECTION | Prescription | Yes | AP | 020221 | CLINIGEN |