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WC 3016 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 Status and FDA Approval Process 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

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