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Serving leading biopharmaceutical companies globally:

Teva
Julphar
Baxter
Fish and Richardson
Mallinckrodt
Cerilliant
UBS
Merck
Dow
Daiichi Sankyo

Generated: November 24, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076583

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NDA 076583 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 076583

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

Medical Subject Heading (MeSH) Categories for 076583

Suppliers and Packaging for NDA: 076583

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOROLAC TROMETHAMINE
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC 076583 ANDA Falcon Pharmaceuticals, Ltd. 61314-126 61314-126-05 5 mL in 1 BOTTLE (61314-126-05)
KETOROLAC TROMETHAMINE
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC 076583 ANDA Falcon Pharmaceuticals, Ltd. 61314-126 61314-126-10 10 mL in 1 BOTTLE (61314-126-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.5%
Approval Date:Nov 5, 2009TE:ATRLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Teva
US Department of Justice
Daiichi Sankyo
Deloitte
Queensland Health
Mallinckrodt
QuintilesIMS
Fuji
Johnson and Johnson

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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