Details for New Drug Application (NDA): 204216
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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 204216
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Gland |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Pharmacology for NDA: 204216
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 204216
Suppliers and Packaging for NDA: 204216
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 204216 | ANDA | Henry Schein, Inc. | 0404-9883 | 0404-9883-01 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9883-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 204216 | ANDA | Henry Schein, Inc. | 0404-9996 | 0404-9996-01 | 1 VIAL in 1 BAG (0404-9996-01) / 1 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Nov 1, 2016 | TE: | AP | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Nov 1, 2016 | TE: | AP | RLD: | No |
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