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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021371
Company: EXELTIS USA INC

Products on NDA 021371

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRASORB	ESTRADIOL HEMIHYDRATE	0.25%	EMULSION;TOPICAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021371

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/09/2003	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21371_estrasorb_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21371ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-371_Estrasorb.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021371Orig1s010ltr.pdf
11/01/2017	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf
03/10/2015	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021371s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021371Orig1s007ltr.pdf

Labels for NDA 021371

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021371s010lbl.pdf
11/01/2017	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf
11/01/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021371s008lbl.pdf
03/10/2015	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021371s007lbl.pdf
10/09/2003	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21371_estrasorb_lbl.pdf

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