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WC 3016 FDA Approval Status

FDA Approved: No
Brand name: WC 3016
Company: Warner Chilcott Limited
Treatment for: Birth Control

WC 3016 is a low dose oral contraceptive in intended for birth control.

In January 2010, Warner Chilcott Limited announced the receipt of a complete response letter for WC 3016 from the U.S. Food and Drug Administration (FDA) citing manufacturing deficiencies.

Development timeline for WC 3016

Jan 28, 2010FDA Issues Complete Response Letter for Low Dose Oral Contraceptive WC 3016
May 27, 2009Warner Chilcott Announces FDA Acceptance of NDA Submission for Low Dose Oral Contraceptive

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.