Details for New Drug Application (NDA): 075784
✉ 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 075784
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Fresenius Kabi Usa |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Pharmacology for NDA: 075784
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 075784
Suppliers and Packaging for NDA: 075784
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075784 | ANDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1594 | 51662-1594-3 | 25 POUCH in 1 CASE (51662-1594-3) / 1 VIAL, SINGLE-USE in 1 POUCH (51662-1594-2) / 1 mL in 1 VIAL, SINGLE-USE |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 075784 | ANDA | Cardinal Health 107, LLC | 55154-9366 | 55154-9366-5 | 5 VIAL, SINGLE-USE in 1 BAG (55154-9366-5) / 1 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Jan 11, 2002 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Jan 11, 2002 | TE: | AP | RLD: | No |
Complete Access Available with Subscription