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Generated: October 22, 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 Cycle Pharms Ltd, Apotex Inc, Hospira, Amphastar Pharm, Gland Pharma Ltd, Sun Pharma Global, Alcon Pharms Ltd, West-ward Pharms Int, Bedford, Baxter Hlthcare Corp, Akorn, Fresenius Kabi Usa, Wockhardt, Luitpold, Apothecon, Teva, Mylan Labs Ltd, Watson Labs, Mylan, Sagent Pharms, Sandoz Inc, and Pliva, 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 NDA: 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

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:

Express Scripts
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Chinese Patent Office
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Dow
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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