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Cantor Fitzgerald
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Generated: February 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078434

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NDA 078434 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Amphastar Pharm, Apotex Inc, Apothecon, Baxter Hlthcare Corp, Bedford, Cycle Pharms Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Sandoz Inc, Sun Pharma Global, West-ward Pharms Int, Wockhardt, Akorn, Mylan, Pliva, Teva, and Watson Labs, and is included in thirty-nine NDAs. It is available from forty-nine suppliers. Additional details are available on the KETOROLAC TROMETHAMINE profile page.

The generic ingredient in KETOROLAC TROMETHAMINE is ketorolac tromethamine. There are eighteen drug master file entries for this compound. Fifty-three suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.
Summary for 078434
Tradename:KETOROLAC TROMETHAMINE
Applicant:Akorn
Ingredient:ketorolac tromethamine
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078434
Medical Subject Heading (MeSH) Categories for 078434
Suppliers and Packaging for NDA: 078434
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078434 ANDA Akorn Inc. 17478-209 N 17478-209-19
KETOROLAC TROMETHAMINE ketorolac tromethamine SOLUTION/DROPS;OPHTHALMIC 078434 ANDA Akorn Inc. 17478-209 N 17478-209-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Nov 5, 2009TE:ATRLD:No

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