FDA Approved: MONTELUKAST SODIUM — Original Application (Dr.Reddy's Laboratories Limited)

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Summary

FDA approves the original ANDA for Montelukast sodium from Dr. Reddy's Laboratories Limited, establishing a generic Montelukast sodium product.

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Diseases / indications

• Asthma
• Exercise-induced Bronchoconstriction
• Perennial Allergic Rhinitis
• Seasonal Allergic Rhinitis

Drugs mentioned

• Montelukast Sodium (Montelukast Sodium)

Snippet

ORIG AP for MONTELUKAST SODIUM (MONTELUKAST SODIUM)