Details for New Drug Application (NDA): 022427
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The generic ingredient in ACUVAIL is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Sixty-eight suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 022427
Tradename: | ACUVAIL |
Applicant: | Abbvie |
Ingredient: | ketorolac tromethamine |
Patents: | 4 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 022427
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 022427
Suppliers and Packaging for NDA: 022427
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427 | NDA | Allergan, Inc. | 0023-3507 | 0023-3507-05 | 5 VIAL, SINGLE-DOSE in 1 CARTON (0023-3507-05) / .4 mL in 1 VIAL, SINGLE-DOSE |
ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427 | NDA | Allergan, Inc. | 0023-3507 | 0023-3507-31 | 3 POUCH in 1 CARTON (0023-3507-31) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.45% | ||||
Approval Date: | Jul 22, 2009 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 15, 2029 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Mar 7, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 5, 2024 | Product Flag? | Y | Substance Flag? | Delist Request? |
Expired US Patents for NDA 022427
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ACUVAIL | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 022427-001 | Jul 22, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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