Sertraline hydrochloride is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Ranbaxy Labs Ltd, Roxane, Pfizer, Accord Hlthcare, Actavis Elizabeth, Apotex Inc, Austarpharma Llc, Cipla Ltd, Dr Reddys Labs Ltd, Hikma Pharms, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Mutual Pharm, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Prosam Labs, Ranbaxy, Sandoz, Sun Pharm Inds (in), Teva, Torrent Pharms, Watson Labs, Wockhardt, and Zydus Pharms Usa, and is included in thirty-one NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
There are twenty-two drug master file entries for sertraline hydrochloride. Thirteen suppliers are listed for this compound. There is one tentative approval 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||077818||Feb 6, 2007||DISCN||No||<disabled>||<disabled>|
|TABLET;ORAL||019839||Dec 30, 1991||RX||No||<disabled>||<disabled>|
|TABLET;ORAL||078677||Mar 4, 2009||RX||No||<disabled>||<disabled>|
|CONCENTRATE;ORAL||020990||Dec 7, 1999||RX||Yes||6,727,283*PED||<disabled>||Y||<disabled>|
|TABLET;ORAL||078175||Jul 21, 2010||RX||No||<disabled>||<disabled>|
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