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FDA approval · 2023-10-24

FDA Approved: THEOPHYLLINE — Original Application (Harman Finochem Limited)

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Summary

FDA approved Harman Finochem Limited's original application for Theophylline, enabling its generic manufacture and marketing under an ANDA Original Application.

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Diseases / indications

Drugs mentioned

  • Theophylline (Theophylline)

Snippet

ORIG AP for THEOPHYLLINE (THEOPHYLLINE)