Hydromorphone hydrochloride is the generic ingredient in five branded drugs marketed by Purdue Pharma Lp, Purdue Pharm Prods, Akorn, Barr, Hospira, Hospira Inc, Watson Labs, Roxane, Mallinckrodt Inc, Actavis Labs Fl Inc, Elite Labs, Lannett, Mallinckrodt, and Nesher Pharms, and is included in twenty-one NDAs. There are eight patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are eleven drug master file entries for hydromorphone hydrochloride. Eleven 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|
Purdue Pharm Prods
|INJECTABLE;INJECTION||019034||Aug 4, 1994||RX||Yes||6,589,960||<disabled>||Y||<disabled>|
|TABLET;ORAL||077311||Nov 9, 2005||DISCN||No||<disabled>||<disabled>|
|TABLET, EXTENDED RELEASE;ORAL||021217||Mar 1, 2010||RX||No||5,702,725||<disabled>||Y||<disabled>|
|TABLET;ORAL||074597||Jul 29, 1998||RX||No||<disabled>||<disabled>|
|TABLET, EXTENDED RELEASE;ORAL||021217||Aug 24, 2012||RX||Yes||5,702,725||<disabled>||Y||<disabled>|
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