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, Cycle Pharms Ltd, Mylan, Pliva, Teva, Watson Labs, and Omeros, and is included in fourty-four NDAs. There are ten 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.
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|INJECTABLE;INJECTION||074802||Jun 5, 1997||RX||Yes||<disabled>||<disabled>|
|SPRAY, METERED;NASAL||022382||May 14, 2010||RX||Yes||6,333,044||<disabled>||Y||<disabled>|
|INJECTABLE;INJECTION||077943||Mar 27, 2007||DISCN||No||<disabled>||<disabled>|
|INJECTABLE;INJECTION||075228||Apr 26, 1999||DISCN||No||<disabled>||<disabled>|
|SOLUTION/DROPS;OPHTHALMIC||021528||May 30, 2003||RX||Yes||8,377,982*PED||<disabled>||Y||<disabled>|
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