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FDA approval · 2021-04-23

FDA Approved: DICYCLOMINE HYDROCHLORIDE — Original Application (Novitium Pharma LLC)

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Summary

The FDA approved Novitium Pharma LLC's original ANDA for dicyclomine hydrochloride, enabling a generic version to enter the market.

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Diseases / indications

Drugs mentioned

  • Dicyclomine hydrochloride (Dicyclomine hydrochloride)

Snippet

ORIG AP for DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)