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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Deloitte
US Department of Justice
Dow
Argus Health
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Express Scripts
Harvard Business School
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Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078088

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NDA 078088 describes ALPRAZOLAM, which is a drug marketed by West-ward Pharms Int, 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, Par Pharm, Dava Intl Inc, Ivax Sub Teva Pharms, Mylan Pharms Inc, Natco Pharma Ltd, Sandoz, Sun Pharma Global, Vintage, and Watson Labs, and is included in thirty-five NDAs. It is available from fifty-two suppliers. Additional details are available on the ALPRAZOLAM profile page.

The generic ingredient in ALPRAZOLAM is alprazolam. There are fifteen drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the alprazolam profile page.

Summary for 078088

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 078088

Ingredient-typeBenzodiazepines

Medical Subject Heading (MeSH) Categories for 078088

Suppliers and Packaging for NDA: 078088

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 078088 ANDA Par Pharmaceutical, Inc. 49884-110 49884-110-74 10 BLISTER PACK in 1 CARTON (49884-110-74) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK
ALPRAZOLAM alprazolam TABLET, ORALLY DISINTEGRATING;ORAL 078088 ANDA Par Pharmaceutical, Inc. 49884-111 49884-111-74 10 BLISTER PACK in 1 CARTON (49884-111-74) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.25MG
Approval Date:Jan 9, 2009TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength0.5MG
Approval Date:Jan 9, 2009TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength1MG
Approval Date:Jan 9, 2009TE:ABRLD:No


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Serving leading biopharmaceutical companies globally:

Colorcon
Merck
QuintilesIMS
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Cerilliant
Covington
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Healthtrust
Cantor Fitzgerald
US Department of Justice

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