Details for New Drug Application (NDA): 090017
✉ Email this page to a colleague
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 090017
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Sun Pharm |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 090017
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 090017
Suppliers and Packaging for NDA: 090017
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 090017 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-219 | 47335-219-90 | 1 BOTTLE, DROPPER in 1 CARTON (47335-219-90) / 3 mL in 1 BOTTLE, DROPPER |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 090017 | ANDA | Sun Pharmaceutical Industries, Inc. | 47335-220 | 47335-220-90 | 1 BOTTLE, DROPPER in 1 CARTON (47335-220-90) / 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: | Nov 5, 2009 | TE: | AT | RLD: | No |
Complete Access Available with Subscription