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Details for Generic Name: ketorolac tromethamine

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Ketorolac tromethamine is the generic ingredient in eight branded drugs marketed by Agila Speclts, Amphastar Pharm, Apotex Inc, Apothecon, Bedford, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma Maple , Hospira, Luitpold, Sagent Pharms, Sandoz, Sun Pharma Global, Wockhardt, Roche Palo, Allergan, Akorn, Alcon Pharms Ltd, Egalet Us Inc, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Omeros, and is included in fourty-four NDAs. There are twelve patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for ketorolac tromethamine. Seven suppliers are listed for this compound.

Summary for Generic Name: ketorolac tromethamine

Tradenames:8
Patents:12
Applicants:25
NDAs:44
Drug Master File Entries: see list16
Suppliers: see list7
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: ketorolac tromethamine

Clinical Trials for: ketorolac tromethamine

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan
ACULAR LS
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC021528-001May 30, 2003RXYes8,648,107<disabled>Y<disabled>
Allergan
ACULAR
ketorolac tromethamine
SOLUTION/DROPS;OPHTHALMIC019700-001Nov 9, 1992RXYes<disabled><disabled>
Bedford
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION075230-001Oct 25, 1999DISCNNo<disabled><disabled>
Luitpold
KETOROLAC TROMETHAMINE
ketorolac tromethamine
INJECTABLE;INJECTION078145-002Jan 14, 2008DISCNNo<disabled><disabled>
Watson Labs
KETOROLAC TROMETHAMINE
ketorolac tromethamine
TABLET;ORAL074955-001Sep 19, 1997DISCNNo<disabled><disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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