Product Details for ANDA 075222
KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOROLAC TROMETHAMINE
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075222
Product Number: 001
Approval Date: Apr 26, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
KETOROLAC TROMETHAMINE (KETOROLAC TROMETHAMINE)
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075222
Product Number: 001
Approval Date: Apr 26, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: KETOROLAC TROMETHAMINE
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075222
Product Number: 002
Approval Date: Apr 26, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information
Proprietary Name: KETOROLAC TROMETHAMINE
Dosage Form; Route of Administration: INJECTABLE; INJECTION
Strength: 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: No
Reference Standard: No
TE Code:
Application Number: A075222
Product Number: 002
Approval Date: Apr 26, 1999
Applicant Holder Full Name: HIKMA PHARMACEUTICALS USA INC
Marketing Status: Discontinued
Patent and Exclusivity Information