Details for New Drug Application (NDA): 076722
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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 076722
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Gland Pharma Ltd |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 076722
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 076722
Suppliers and Packaging for NDA: 076722
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 076722 | ANDA | Gland Pharma Limited | 68083-103 | 68083-103-01 | 10 SYRINGE in 1 CARTON (68083-103-01) / 1 mL in 1 SYRINGE |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 076722 | ANDA | Gland Pharma Limited | 68083-104 | 68083-104-01 | 10 SYRINGE in 1 CARTON (68083-104-01) / 1 mL in 1 SYRINGE |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Jul 27, 2004 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Jul 27, 2004 | TE: | RLD: | No |
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