Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 020847
Company: WOMEN FIRST HLTHCARE
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESCLIM ESTRADIOL 0.025MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
ESCLIM ESTRADIOL 0.0375MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
ESCLIM ESTRADIOL 0.05MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
ESCLIM ESTRADIOL 0.075MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
ESCLIM ESTRADIOL 0.1MG/24HR FILM, EXTENDED RELEASE;TRANSDERMAL Discontinued None No No
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.

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

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English