FDA corrects withdrawal notice of 16 ANDAs
The FDA issued a correction to a June 3, 2026 notice that announced the withdrawal of approval of 16 abbreviated new drug applications, effective July 6, 2026. The correction removes entries for ANDA 207366, ANDA 212957, and ANDA 218638, noting that Navinta LLC requested the approvals not be withdrawn, so those approvals remain in effect.
Primary source
Federal Register notice, October 9, 2026
Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction
Read the source: Elite Laboratories, Inc. et al.; Withdrawal of Approval of 16 Abbreviated New Drug Applications; Correction federalregister.gov
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