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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202906

MONTELUKAST SODIUM (MONTELUKAST SODIUM)
EQ 4MG BASE/PACKET
Marketing Status: Prescription
Active Ingredient: MONTELUKAST SODIUM
Proprietary Name: MONTELUKAST SODIUM
Dosage Form; Route of Administration: GRANULE; ORAL
Strength: EQ 4MG BASE/PACKET
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202906
Product Number: 001
Approval Date: Sep 17, 2012
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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