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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Baxter
Cipla
AstraZeneca
McKesson
Johnson and Johnson
Mallinckrodt
Deloitte
Queensland Health
Accenture
Colorcon

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076209

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NDA 076209 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 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 076209

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

Pharmacology for NDA: 076209

Medical Subject Heading (MeSH) Categories for 076209

Suppliers and Packaging for NDA: 076209

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION 076209 ANDA Amphastar Pharmaceuticals, Inc. 0548-9021 0548-9021-00 10 VIAL in 1 CARTON (0548-9021-00) > 1 mL in 1 VIAL
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION 076209 ANDA REMEDYREPACK INC. 70518-0504 70518-0504-0 1 mL in 1 VIAL (70518-0504-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength15MG/ML
Approval Date:Jul 21, 2004TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength30MG/ML
Approval Date:Jul 21, 2004TE:APRLD:No


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Serving leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Chubb
Colorcon
Fish and Richardson
Healthtrust
Federal Trade Commission
UBS
Teva
AstraZeneca

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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