Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by Dava Pharms Inc, Mutual Pharm, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Watson Labs, Pfizer, Pharm Assoc, Silarx, Teva Pharms, Wockhardt, Fougera Pharms, Actavis Elizabeth, and Pernix Theraps Llc, and is included in fifty-eight NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
There are seven drug master file entries for doxepin hydrochloride. Four suppliers are listed for this compound. There are three tentative approvals for this compound.
|Drug Class||Tricyclic Antidepressant |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Type||RLD||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|CAPSULE;ORAL||072110||Sep 8, 1988||DISCN||No||<disabled>||<disabled>|
|CAPSULE;ORAL||071669||Nov 9, 1987||RX||No||<disabled>||<disabled>|
|CONCENTRATE;ORAL||071918||Jul 20, 1988||RX||No||<disabled>||<disabled>|
|CAPSULE;ORAL||071486||Apr 30, 1987||DISCN||No||<disabled>||<disabled>|
Pernix Theraps Llc
|TABLET;ORAL||022036||Mar 17, 2010||RX||No||6,211,229||<disabled>||<disabled>|
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