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Hydrocodone Bitartrate AND Acetaminophen · Regulatory label update
U.S. Food and Drug Administration · June 18, 2026
An action by a regulator. Authoritative on labelling and availability.
This is an FDA supplemental approval (REMS) for hydrocodone bitartrate-acetaminophen combination tablets in three dose strengths (5 mg, 7.5 mg, and 10 mg hydrocodone with 300 mg acetaminophen) by Novel Labs Inc., dated 18 June 2026. The record confirms regulatory authorization of a Risk Evaluation and Mitigation Strategy but does not contain clinical trial results, efficacy data, or safety outcomes.
Regulatory label update. Intervention: Hydrocodone bitartrate-acetaminophen tablets in three dose strengths: 5 mg + 300 mg, 7.5 mg + 300 mg, and 10 mg + 300 mg.
Approval granted for REMS supplement on 2026-06-18 for application ANDA206142 Three tablet formulations approved: 5 mg, 7.5 mg, and 10 mg hydrocodone bitartrate with 300 mg acetaminophen
This record does not contain clinical trial results, efficacy data, or safety outcome comparisons
This regulatory action permits Novel Labs Inc. to market the specified hydrocodone-acetaminophen formulations under a REMS program; it does not itself provide evidence of efficacy or safety superiority. Clinicians should consult the approved product labeling and REMS requirements for prescribing guidance.
FDA supplemental approval of a Risk Evaluation and Mitigation Strategy (REMS) for an existing hydrocodone-acetaminophen combination, a regulatory action rather than a clinical evidence assessment.
As stated by the source record.
Quoted from the source exactly as published.
This regulatory action permits Novel Labs Inc. to market the specified hydrocodone-acetaminophen formulations under a REMS program; it does not itself provide evidence of efficacy or safety superiority. Clinicians should consult the approved product labeling and REMS requirements for prescribing guidance.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Drugs@FDA record for application ANDA206142. This is a regulatory action record, not a clinical study. Brand name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Active ingredient: HYDROCODONE BITARTRATE AND ACETAMINOPHEN. Sponsor: NOVEL LABS INC. Submission type: SUPPL (supplement). Submission class: REMS. Approval status date: 2026-06-18. Products: HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 300MG + HYDROCODONE BITARTRATE 10MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 300MG + HYDROCODONE BITARTRATE 5MG; HYDROCODONE BITARTRATE AND ACETAMINOPHEN, TABLET, ORAL, ACETAMINOPHEN 300MG + HYDROCODONE BITARTRATE 7.5MG.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.