Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 021102
Company: WARNER CHILCOTT
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FEMHRT ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.005MG;1MG TABLET; ORAL Prescription 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
10/15/1999 ORIG-1 Approval Type 6 - New Indication (no longer used) STANDARD Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/021102_s000_21065_FemhrtTOC.cfm

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