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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022014
Company: PADAGIS US

Other Important Information from FDA

Summary Review

Products on NDA 022014

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVAMIST	ESTRADIOL	1.53MG/SPRAY	SPRAY;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022014

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/2007	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022014s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022014_evamist_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/022014s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/022014Orig1s015ltr.pdf
08/03/2023	SUPPL-14	Labeling-Container/Carton Labels, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022014s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/022014Orig1s014ltr.pdf
11/01/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022014s013lbl.pdf
01/15/2013	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
10/26/2011	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022014s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022014s009ltr.pdf
03/11/2014	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022014s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022014Orig1s006ltr.pdf
10/30/2008	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022014s005ltr.pdf
04/11/2008	SUPPL-1	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022014s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022014s001ltr.pdf

Labels for NDA 022014

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022014s015lbl.pdf
08/03/2023	SUPPL-14	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022014s014lbl.pdf
08/03/2023	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022014s014lbl.pdf
11/01/2017	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022014s013lbl.pdf
03/11/2014	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022014s006lbl.pdf
10/26/2011	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022014s009lbl.pdf
04/11/2008	SUPPL-1	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022014s001lbl.pdf
07/27/2007	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022014lbl.pdf

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