Details for New Drug Application (NDA): 201155
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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 201155
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Steriscience |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 201155
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 201155
Suppliers and Packaging for NDA: 201155
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 201155 | ANDA | Steriscience Specialties Private Limited | 82449-218 | 82449-218-01 | 1 SYRINGE, GLASS in 1 CARTON (82449-218-01) / 1 mL in 1 SYRINGE, GLASS |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | INJECTABLE;INJECTION | 201155 | ANDA | Steriscience Specialties Private Limited | 82449-219 | 82449-219-01 | 1 SYRINGE, GLASS in 1 CARTON (82449-219-01) / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 15MG/ML | ||||
Approval Date: | Aug 4, 2014 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 30MG/ML | ||||
Approval Date: | Aug 4, 2014 | TE: | RLD: | No |
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