Details for New Drug Application (NDA): 217038
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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 217038
Tradename: | KETOROLAC TROMETHAMINE |
Applicant: | Zydus |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 217038
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 217038
Suppliers and Packaging for NDA: 217038
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
KETOROLAC TROMETHAMINE | ketorolac tromethamine | TABLET;ORAL | 217038 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-2983 | 68071-2983-2 | 20 TABLET, FILM COATED in 1 BOTTLE (68071-2983-2) |
KETOROLAC TROMETHAMINE | ketorolac tromethamine | TABLET;ORAL | 217038 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3591 | 68071-3591-4 | 4 TABLET, FILM COATED in 1 BOTTLE (68071-3591-4) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 21, 2022 | TE: | AB | RLD: | No |
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