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FDA approval · 2025-08-01

FDA Approved: PRAMIPEXOLE DIHYDROCHLORIDE — Supplemental Application (Macleods Pharmaceuticals Limited)

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Summary

The FDA approved a supplemental ANDA for Pramipexole dihydrochloride by Macleods Pharmaceuticals Limited, enabling marketing of a generic product.

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Diseases / indications

Drugs mentioned

  • Pramipexole dihydrochloride (pramipexole dihydrochloride)

Snippet

SUPPL AP for PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)