Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020221
Company: CLINIGEN HLTHCARE
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
AMIFOSTINE AMIFOSTINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 204363 MYLAN LABS LTD
AMIFOSTINE AMIFOSTINE 500MG/VIAL INJECTABLE;INJECTION Prescription No AP 077126 SUN PHARM
ETHYOL AMIFOSTINE 500MG/VIAL INJECTABLE;INJECTION Prescription Yes AP 020221 CLINIGEN HLTHCARE

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