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Last Updated: December 7, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203376


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NDA 203376 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Amphastar Pharm, Apotex Inc, Apothecon, Atlantide, Baxter Hlthcare Corp, Bedford, Eugia Pharma, Fresenius Kabi Usa, Gland, Gland Pharma Ltd, Hikma Pharms, Hospira, Luitpold, Mylan Labs Ltd, Nephron, Sagent Pharms Inc, Sandoz Inc, Sun Pharm, Wockhardt, Akorn, Micro Labs Ltd India, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Lupin Ltd, and is included in forty-six NDAs. It is available from forty-four suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.

The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine; phenylephrine hydrochloride. There are eighteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ketorolac tromethamine; phenylephrine hydrochloride profile page.
Summary for 203376
Tradename:KETOROLAC TROMETHAMINE
Applicant:Akorn
Ingredient:ketorolac tromethamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203376
Mechanism of ActionCyclooxygenase Inhibitors
Medical Subject Heading (MeSH) Categories for 203376
Suppliers and Packaging for NDA: 203376
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 203376 ANDA Akorn 17478-207 17478-207-14 30 VIAL, SINGLE-USE in 1 CARTON (17478-207-14) > .4 mL in 1 VIAL, SINGLE-USE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrength0.45%
Approval Date:Feb 10, 2014TE:RLD:No

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