Details for New Drug Application (NDA): 218204
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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 218204
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Caplin |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Pharmacology for NDA: 218204
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218204
Suppliers and Packaging for NDA: 218204
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 218204 | ANDA | Caplin Steriles Limited | 65145-138 | 65145-138-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-138-01) / 3 mL in 1 BOTTLE, DROPPER |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 218204 | ANDA | Caplin Steriles Limited | 65145-139 | 65145-139-01 | 1 BOTTLE, DROPPER in 1 CARTON (65145-139-01) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | Mar 26, 2024 | TE: | AT | RLD: | No |
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