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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 204308
Company: AZURITY

Summary Review

Products on NDA 204308

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPANED KIT	ENALAPRIL MALEATE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SOLUTION;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 204308

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.

Labels for NDA 204308

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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