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Naltrexone hydrochlorideis the generic ingredient in three branded drugs marketed by Accord Hlthcare, Apotex, Barr, Elite Labs, Fosun Pharma, Specgx Llc, Sun Pharm, Teva Womens, and Pfizer Inc, and is included in nine NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.
There are nineteen drug master file entries for naltrexone hydrochloride. Eleven suppliers are listed for this compound.
Recent Clinical Trials for NALTREXONE HYDROCHLORIDE
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|Oslo University Hospital||Phase 4|
|Hennepin Healthcare Research Institute||Phase 2/Phase 3|
|Stanford University||Phase 2|
Pharmacology for NALTREXONE HYDROCHLORIDE
|Drug Class||Opioid Antagonist |
|Mechanism of Action||Opioid Antagonists |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Pfizer Inc||TROXYCA ER||naltrexone hydrochloride; oxycodone hydrochloride||CAPSULE, EXTENDED RELEASE;ORAL||207621-006||Aug 19, 2016||DISCN||No||No||Start Trial||Start Trial||Y||Start Trial|
|Pfizer Inc||TROXYCA ER||naltrexone hydrochloride; oxycodone hydrochloride||CAPSULE, EXTENDED RELEASE;ORAL||207621-003||Aug 19, 2016||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Fosun Pharma||NALTREXONE HYDROCHLORIDE||naltrexone hydrochloride||TABLET;ORAL||075434-001||Mar 8, 2000||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Pfizer Inc||TROXYCA ER||naltrexone hydrochloride; oxycodone hydrochloride||CAPSULE, EXTENDED RELEASE;ORAL||207621-006||Aug 19, 2016||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Apotex||NALTREXONE HYDROCHLORIDE||naltrexone hydrochloride||TABLET;ORAL||207905-001||Jul 21, 2017||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Pfizer Inc||TROXYCA ER||naltrexone hydrochloride; oxycodone hydrochloride||CAPSULE, EXTENDED RELEASE;ORAL||207621-004||Aug 19, 2016||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
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