Details for New Drug Application (NDA): 074754
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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 074754
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Teva |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Pharmacology for NDA: 074754
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 074754
Suppliers and Packaging for NDA: 074754
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | TABLET;ORAL | 074754 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-0314 | 0093-0314-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0314-01) |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | TABLET;ORAL | 074754 | ANDA | Lake Erie Medical DBA Quality Care Products LLC | 35356-696 | 35356-696-10 | 10 TABLET, FILM COATED in 1 BOTTLE (35356-696-10) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | May 16, 1997 | TE: | AB | RLD: | No |
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