Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications

Jurisdiction: Statewide, NH New Hampshire statewide County, NH
Recorded by: Federal RegisterPublic source — not a Notice Nearby paid publication
Placement start: Oct 9, 2026, 7:00 AM PDT
Placement end: October 8, 2027
Publication fee: Sourced listing · no Notice Nearby fee
Run schedule: 1 insertion: October 9, 2026
File / case: 2026-20762
Parties: Health and Human Services Department; Food and Drug Administration
Original source: https://www.federalregister.gov/documents/2026/10/09/2026-20762/par-health-usa-llc-us-agent-for-ph-health-limited-et-al-withdrawal-of-approval-of-37-abbreviated-newSourced from Federal Register

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Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applications The Food and Drug Administration (FDA or Agency) is withdrawing approval of 37 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. Agency: Health and Human Services Department; Food and Drug Administration. Source: Federal Register Published: 2026-10-09 Original: https://www.federalregister.gov/documents/2026/10/09/2026-20762/par-health-usa-llc-us-agent-for-ph-health-limited-et-al-withdrawal-of-approval-of-37-abbreviated-new This listing was added to the Notice Nearby public register from a public government source. It is not a Notice Nearby paid publication, affidavit, or placement certificate.

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published · Federal RegisterOct 9, 2026, 7:00 AM PDT

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