FDA ANDA and 505(b)(2) Approvals - First Quarter 2026

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FDA ANDA and 505(b)(2) Approvals - First Quarter 2026

JD Supra Healthcare

Detected April 17th, 2026

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Summary

JD Supra Healthcare published a compilation tracking FDA Abbreviated New Drug Application and 505(b)(2) Application approvals for Q1 2026 (January through late March). The chart lists over 100 final generic drug approvals, including approval dates, reference-listed drugs, generic drug names, NDA holders, ANDA applicants, and ANDA numbers. Companies represented include Taro, Glenmark, Sandoz, Amneal, Apotex, Zydus, and numerous other generic manufacturers.

Published by JD Supra on jdsupra.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

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This document is a reference compilation listing FDA final approvals of Abbreviated New Drug Applications (ANDAs) and 505(b)(2) applications during the first quarter of 2026. It catalogs approvals by date, reference-listed brand drug, generic drug name, NDA holder, ANDA applicant, and ANDA number. The compilation covers approximately 100+ generic drug approvals across January through late March 2026.

For pharmaceutical manufacturers and applicants, this document serves as an informational reference confirming FDA final approval status for specific generic drug products. Generic drug applicants can identify competitors that have received approval for the same reference-listed drugs, which may inform competitive positioning and pricing strategy. Healthcare providers and patients may reference this compilation to identify newly available generic alternatives to brand-name medications.

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Apr 17, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

April 16, 2026

ANDA Approvals - First Quarter 2026

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Abbreviated New Drug Application and 505(b)(2) Application Approvals

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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Abbreviated New Drug Application (ANDA) + Follow FDA Approval + Follow Food & Drug Regulations + Follow Generic Drugs + Follow Hatch-Waxman + Follow Manufacturers + Follow Pharmaceutical Industry + Follow Prescription Drugs + Follow Health + Follow Science, Computers & Technology + Follow

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April 17, 2026

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JD Supra

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Pharmaceutical companies Drug manufacturers

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3254 Pharmaceutical Manufacturing

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Generic drug approvals Pharmaceutical regulation FDA approvals

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United States US

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Pharmaceuticals

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Regulatory Affairs

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Healthcare Intellectual Property

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FDA ANDA and 505(b)(2) Approvals - First Quarter 2026

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ANDA Approvals - First Quarter 2026

Abbreviated New Drug Application and 505(b)(2) Application Approvals

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