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Alprazolamis the generic ingredient in four branded drugs marketed by Hikma, Roxane, Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Anchen Pharms, Ani Pharms Inc, Apotex Inc, Aurobindo Pharma Ltd, Heritage Pharms Inc, Impax Labs, Impax Labs Inc, Mylan, Sandoz Inc, Vintage Pharms, Upjohn, Par Pharm, Ucb Inc, Breckenridge, Dava Intl Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Oxford Pharms, Sandoz, Sun Pharm, and Watson Labs, and is included in thirty-nine NDAs. Additional information is available in the individual branded drug profile pages.
There are fifteen drug master file entries for alprazolam. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for ALPRAZOLAM
Recent Clinical Trials for ALPRAZOLAM
Identify potential brand extensions & 505(b)(2) entrants
|Istanbul Medeniyet University||Phase 4|
|University of Illinois at Chicago||Phase 1|
|Oregon State University||Phase 1|
Generic filers with tentative approvals for ALPRAZOLAM
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ALPRAZOLAM
|Drug Class||Benzodiazepine |
Medical Subject Heading (MeSH) Categories for ALPRAZOLAM
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Mylan Pharms Inc||ALPRAZOLAM||alprazolam||TABLET;ORAL||074046-002||Oct 19, 1993||DISCN||No||No||Start Trial||Start Trial||Start Trial|
|Sun Pharm||ALPRAZOLAM||alprazolam||TABLET;ORAL||090082-001||Jun 17, 2010||AB||RX||No||No||Start Trial||Start Trial||Start Trial|
|Heritage Pharms Inc||ALPRAZOLAM||alprazolam||TABLET, EXTENDED RELEASE;ORAL||078489-002||Oct 17, 2008||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|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Ucb Inc||NIRAVAM||alprazolam||TABLET, ORALLY DISINTEGRATING;ORAL||021726-001||Jan 19, 2005||Start Trial||Start Trial|
|Upjohn||XANAX||alprazolam||TABLET;ORAL||018276-004||Nov 27, 1985||Start Trial||Start Trial|
|Upjohn||XANAX||alprazolam||TABLET;ORAL||018276-003||Approved Prior to Jan 1, 1982||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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