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Serving 500+ biopharmaceutical companies globally:

Fish and Richardson
US Army
Cantor Fitzgerald
Boehringer Ingelheim
US Department of Justice
Argus Health

Generated: August 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075772

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NDA 075772 describes KETOROLAC TROMETHAMINE, which is a drug marketed by Apotex Inc, Hospira, Amphastar Pharm, Gland Pharma Ltd, Sun Pharma Global, Alcon Pharms Ltd, West-ward Pharms Int, Bedford, Claris, Akorn, Fresenius Kabi Usa, Wockhardt, Luitpold, Apothecon, Teva, Mylan Labs Ltd, Watson Labs, Mylan, Sagent Pharms, Sandoz Inc, Pliva, and Cycle Pharms Ltd, and is included in thirty-eight NDAs. It is available from forty-eight 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-two suppliers are listed for this compound. Additional details are available on the ketorolac tromethamine profile page.

Summary for NDA: 075772

Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 075772

Suppliers and Packaging for NDA: 075772

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ketorolac tromethamine
INJECTABLE;INJECTION 075772 ANDA West-ward Pharmaceutical Corp. 0641-6041 0641-6041-25 25 VIAL in 1 CARTON (0641-6041-25) > 1 mL in 1 VIAL (0641-6041-01)
ketorolac tromethamine
INJECTABLE;INJECTION 075772 ANDA West-ward Pharmaceutical Corp. 0641-6042 0641-6042-25 25 VIAL in 1 CARTON (0641-6042-25) > 1 mL in 1 VIAL (0641-6042-01)

Summary for product number 001

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

Summary for product number 002

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

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Serving 500+ biopharmaceutical companies globally:

US Army
Chinese Patent Office
US Department of Justice

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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