Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204308
Company: SILVERGATE PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EPANED KIT ENALAPRIL MALEATE 1MG/ML FOR SOLUTION;ORAL Discontinued None Yes 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
08/13/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204308s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204308Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204308Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/28/2017 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204308s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204308Orig1s007ltr.pdf
03/22/2017 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204308s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204308Orig1s006ltr.pdf
01/29/2016 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204308s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204308Orig1s005ltr.pdf
12/28/2015 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

09/04/2014 SUPPL-3 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003ltr.pdf
09/04/2014 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/204308Orig1s002,s003ltr.pdf
02/03/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/28/2017 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204308s007lbl.pdf
03/22/2017 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204308s006lbl.pdf
01/29/2016 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204308s005lbl.pdf
09/04/2014 SUPPL-3 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf
09/04/2014 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204308s002s003lbl.pdf
08/13/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204308s000lbl.pdf

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