FDA Approved: TADALAFIL — Original Application (Macleods Pharmaceuticals Limited)

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Summary

FDA approved Macleods Pharmaceuticals Limited's original ANDA for tadalafil, enabling a generic version of the medication.

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Diseases / indications

• Benign Prostatic Hyperplasia
• Erectile Dysfunction

Drugs mentioned

• TADALAFIL (TADALAFIL)

Snippet

ORIG AP for TADALAFIL (TADALAFIL)