Details for New Drug Application (NDA): 214456
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The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 214456
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Alembic |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Pharmacology for NDA: 214456
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 214456
Suppliers and Packaging for NDA: 214456
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 214456 | ANDA | A-S Medication Solutions | 50090-6772 | 50090-6772-0 | 25 VIAL in 1 CARTON (50090-6772-0) / 2 mL in 1 VIAL |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 214456 | ANDA | A-S Medication Solutions | 50090-6772 | 50090-6772-1 | 1 VIAL in 1 CARTON (50090-6772-1) / 2 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Nov 2, 2022 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Nov 2, 2022 | TE: | AP | RLD: | No |
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