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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021409

SINGULAIR (MONTELUKAST SODIUM)
EQ 4MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: MONTELUKAST SODIUM
Proprietary Name: SINGULAIR
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 4MG BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021409
Product Number: 001
Approval Date: Jul 26, 2002
Applicant Holder Full Name: ORGANON LLC A SUB OF ORGANON AND CO
Marketing Status:  Prescription
Patent and Exclusivity Information
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