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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022382

SPRIX (KETOROLAC TROMETHAMINE)
15.75MG/SPRAY
Marketing Status: Prescription
Active Ingredient: KETOROLAC TROMETHAMINE
Proprietary Name: SPRIX
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 15.75MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022382
Product Number: 001
Approval Date: May 14, 2010
Applicant Holder Full Name: ZYLA LIFE SCIENCES US INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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