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FDA approval · 2026-01-09

FDA Approved: VARENICLINE — Original Application (Umedica Laboratories USA Inc.)

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Summary

The FDA approved an original ANDA for varenicline from Umedica Laboratories USA Inc., authorizing a generic version of the smoking-cessation medication.

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Diseases / indications

Drugs mentioned

  • Varenicline (varenicline)

Snippet

ORIG AP for VARENICLINE (VARENICLINE)