Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 209900

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KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
15MG/ML
Marketing Status: Prescription

Active Ingredient: KETOROLAC TROMETHAMINE
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209900
Product Number: 002
Approval Date: Jul 25, 2018
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information

KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
30MG/ML
Marketing Status: Prescription

Active Ingredient: KETOROLAC TROMETHAMINE
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AP
Application Number: A209900
Product Number: 001
Approval Date: Sep 15, 2017
Applicant Holder Full Name: BAXTER HEALTHCARE CORP
Marketing Status:  Prescription
Patent and Exclusivity Information