Details for New Drug Application (NDA): 074802
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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 074802
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Hospira |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Pharmacology for NDA: 074802
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074802
Suppliers and Packaging for NDA: 074802
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 074802 | ANDA | Hospira, Inc. | 0409-3793 | 0409-3793-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3793-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3793-19) |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 074802 | ANDA | Hospira, Inc. | 0409-3795 | 0409-3795-01 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-3795-01) / 1 mL in 1 VIAL, SINGLE-DOSE (0409-3795-19) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Jun 5, 1997 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Jun 5, 1997 | TE: | AP | RLD: | No |
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