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Harvard Business School
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Chinese Patent Office
Express Scripts
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Generated: December 17, 2017

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, 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, Alcon Pharms Ltd, Mylan, Pliva, Teva, and Watson Labs, and is included in thirty-nine NDAs. It is available from fifty 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-four suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for 203376

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 203376

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

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Colorcon
Cerilliant
McKinsey
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Harvard Business School
Cipla
Baxter
AstraZeneca
Deloitte

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