An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021102
Company: WARNER CHILCOTT

Products on NDA 021102

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021102

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

Top