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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075222

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NDA 075222 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, Baxter Hlthcare Corp, 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: 075222

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

Pharmacology for NDA: 075222

Suppliers and Packaging for NDA: 075222

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION 075222 ANDA Cardinal Health 55154-0368 55154-0368-5 5 VIAL in 1 BAG (55154-0368-5) > 1 mL in 1 VIAL
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION 075222 ANDA Cardinal Health 55154-0369 55154-0369-5 5 VIAL in 1 BAG (55154-0369-5) > 2 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength15MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 26, 1999TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Apr 26, 1999TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Daiichi Sankyo
Teva
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Cerilliant

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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