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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020538
Company: SANDOZ

Products on NDA 20538

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADIOL	ESTRADIOL	0.0375MG/24HR	Film, Extended Release; Transdermal	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.075MG/24HR	Film, Extended Release; Transdermal	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.05MG/24HR	Film, Extended Release; Transdermal	Discontinued	None	No	No
ESTRADIOL	ESTRADIOL	0.1MG/24HR	Film, Extended Release; Transdermal	Discontinued	None	No	No
VIVELLE-DOT	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	Yes	No
VIVELLE-DOT	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	Yes	No
VIVELLE-DOT	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	Yes	No
VIVELLE-DOT	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	Yes	Yes
VIVELLE-DOT	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Prescription	AB1	Yes	No

Labels for NDA 020538

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/15/2024	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020538s043lbl.pdf
10/04/2021	SUPPL-39	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538s037;s039lbl.pdf
10/04/2021	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538s037;s039lbl.pdf
09/01/2021	SUPPL-40	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538Orig1s040lbl.pdf
11/01/2017	SUPPL-35	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020538s035lbl.pdf
07/31/2014	SUPPL-32	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf
05/20/2013	SUPPL-30	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
05/20/2013	SUPPL-29	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
05/20/2013	SUPPL-28	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf
08/06/2004	SUPPL-24	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf
01/28/2004	SUPPL-19	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf
05/03/2002	SUPPL-15	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf
05/03/2002	SUPPL-14	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf
05/03/2002	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf
01/08/1999	SUPPL-6	Manufacturing (CMC)-Formulation	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf

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