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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021813
Company: MYLAN SPECIALITY LP

Summary Review

Products on NDA 021813

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ELESTRIN	ESTRADIOL	0.06% (0.87GM/ACTIVATION)	GEL, METERED;TRANSDERMAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021813

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/15/2006	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/2006/021813lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021813s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813_elestrin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021813s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021813s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021813Orig1s014ltr.pdf
10/27/2020	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021813Orig1s007,s009ltr.pdf
10/27/2020	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021813Orig1s007,s009ltr.pdf
11/01/2017	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021813s006lbl.pdf
02/27/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf
02/24/2012	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021813s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021813s003ltr.pdf
02/26/2008	SUPPL-1	Labeling-Container/Carton Labels	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021813s001ltr.pdf

Labels for NDA 021813

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021813s014lbl.pdf
10/27/2020	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf
10/27/2020	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021813s007s009lbl.pdf
11/01/2017	SUPPL-6	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021813s006lbl.pdf
02/27/2014	SUPPL-4	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021813s004lbl.pdf
02/24/2012	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021813s003lbl.pdf
12/15/2006	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021813lbl.pdf

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