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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206185

XELPROS (LATANOPROST)
0.005%
Marketing Status: Prescription
Active Ingredient: LATANOPROST
Proprietary Name: XELPROS
Dosage Form; Route of Administration: EMULSION; OPHTHALMIC
Strength: 0.005%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N206185
Product Number: 001
Approval Date: Sep 12, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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