Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020847
Company: WOMEN FIRST HLTHCARE

Products on NDA 020847

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ESCLIM	ESTRADIOL	0.025MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	No	No
ESCLIM	ESTRADIOL	0.0375MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	No	No
ESCLIM	ESTRADIOL	0.05MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	No	No
ESCLIM	ESTRADIOL	0.075MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	No	No
ESCLIM	ESTRADIOL	0.1MG/24HR	SYSTEM;TRANSDERMAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020847

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/04/1998	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Patient Package Insert (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20847lblmd.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20847ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20847lblpt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20847.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/29/2002	SUPPL-5	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
02/04/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/04/2000	SUPPL-2	Labeling		Label is not available on this site.
09/27/1999	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020847

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/04/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20847lblmd.pdf