Details for New Drug Application (NDA): 019700
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The generic ingredient in ACULAR 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 019700
Tradename: | ACULAR |
Applicant: | Abbvie |
Ingredient: | ketorolac tromethamine |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019700
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for 019700
Suppliers and Packaging for NDA: 019700
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700 | NDA | Allergan, Inc. | 0023-2181 | 0023-2181-05 | 1 BOTTLE, DROPPER in 1 CARTON (0023-2181-05) / 5 mL in 1 BOTTLE, DROPPER |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION/DROPS;OPHTHALMIC | Strength | 0.5% | ||||
Approval Date: | Nov 9, 1992 | TE: | AT | RLD: | Yes |
Expired US Patents for NDA 019700
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ⤷ Sign Up | ⤷ Sign Up |
Abbvie | ACULAR | ketorolac tromethamine | SOLUTION/DROPS;OPHTHALMIC | 019700-001 | Nov 9, 1992 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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