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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 090017

KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
0.5%
Marketing Status: Prescription
Active Ingredient: KETOROLAC TROMETHAMINE
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 0.5%
Reference Listed Drug: No
Reference Standard: No
TE Code: AT
Application Number: A090017
Product Number: 001
Approval Date: Nov 5, 2009
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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