Breckenridge Pharmaceutical, Inc.; Withdrawal of Approval of Abbreviated New Drug Application for Solifenacin Succinate Tablets, 5 Milligrams and 10 Milligrams
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Issuing agencies
Abstract
The Food and Drug Administration (FDA) is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc., 15 Massirio Dr., Berlin, CT 06037 (Breckenridge). Breckenridge requested withdrawal of this application and has waived its opportunity for a hearing.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.