Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019081
Company: NOVARTIS

Products on NDA 19081

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESTRADERM	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	Yes	No
ESTRADERM	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	Yes	No

Labels for NDA 019081

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/01/2017	SUPPL-43	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019081s043lbl.pdf
07/03/2012	SUPPL-42	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf
12/17/2004	SUPPL-40	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf
05/28/2004	SUPPL-39	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf
05/28/2004	SUPPL-36	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf