Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020068
Company: CLINIGEN HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FOSCAVIR FOSCARNET SODIUM 2.4GM/100ML INJECTABLE;INJECTION Prescription None 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
09/27/1991 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/24/2017 SUPPL-23 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020068s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020068Orig1s023ltr.pdf
11/10/2016 SUPPL-22 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020068s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020068Orig1s022ltr.pdf
05/29/2015 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

11/07/2014 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020068Orig1s020ltr.pdf
06/10/2014 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

02/10/2012 SUPPL-18 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf
11/27/2007 SUPPL-17 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf
05/15/2006 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020068s016LTR.pdf
06/13/2000 SUPPL-14 Labeling

Label is not available on this site.

06/13/2000 SUPPL-13 Labeling

Label is not available on this site.

11/16/1998 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

01/03/1997 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1997 SUPPL-9 Labeling

Label is not available on this site.

01/24/1997 SUPPL-8 Labeling

Label is not available on this site.

01/24/1997 SUPPL-7 Efficacy-New Dosing Regimen

Label is not available on this site.

01/24/1997 SUPPL-6 Efficacy-New Indication

Label is not available on this site.

11/17/1995 SUPPL-5 Labeling

Label is not available on this site.

06/16/1995 SUPPL-3 Efficacy-New Indication

Label is not available on this site.

12/12/1995 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
02/24/2017 SUPPL-23 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020068s023lbl.pdf
11/10/2016 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020068s022lbl.pdf
11/07/2014 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf
02/10/2012 SUPPL-18 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf
11/27/2007 SUPPL-17 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf
05/15/2006 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf

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