Tramadol hydrochloride is the generic ingredient in six branded drugs marketed by Cipher Pharms Inc, Purdue Pharma, Actavis Elizabeth, Anchen Pharms, Lupin Ltd, Par Pharm Inc, Sun Pharma Global, Valeant Intl, Shionogi Inc, Accord Hlthcare Inc, Allied Pharma Inc, Amneal Pharms, Apotex, Asta, Aurobindo Pharma Ltd, Cspc Ouyi Pharm Co, Ipca Labs Ltd, Ivax Sub Teva Pharms, Mallinckrodt, Mutual Pharm, Mylan, Mylan Pharms Inc, Northstar Hlthcare, Pliva, Sandoz, Sun Pharm Inds Inc, Teva, Watson Labs, Zydus Pharms Usa Inc, and Janssen Pharms, and is included in thirty-two NDAs. There are seven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.
There are thirty-five drug master file entries for tramadol hydrochloride. Nineteen 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|
|TABLET;ORAL||020281||Mar 3, 1995||DISCN||No||6,339,105*PED||<disabled>||Y||<disabled>|
|TABLET;ORAL||075962||Jun 24, 2002||DISCN||No||<disabled>||<disabled>|
|TABLET;ORAL||020281||Mar 3, 1995||RX||Yes||6,339,105*PED||<disabled>||Y||<disabled>|
|TABLET;ORAL||078935||May 26, 2010||RX||No||<disabled>||<disabled>|
Accord Hlthcare Inc
|TABLET;ORAL||202390||May 16, 2013||RX||No||<disabled>||<disabled>|
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