BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Covington
Mallinckrodt
Harvard Business School
AstraZeneca
McKinsey
Johnson and Johnson
Julphar
Merck
Farmers Insurance
Citi

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078056

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NDA 078056 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-three 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-five suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 078056
Tradename:ALPRAZOLAM
Applicant:Actavis Elizabeth
Ingredient:alprazolam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078056
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 078056
Suppliers and Packaging for NDA: 078056
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056 ANDA Actavis Pharma, Inc. 0228-3083 0228-3083-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3083-06)
ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078056 ANDA Actavis Pharma, Inc. 0228-3084 0228-3084-06 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (0228-3084-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.5MG
Approval Date:Feb 13, 2007TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1MG
Approval Date:Feb 13, 2007TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Feb 13, 2007TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Healthtrust
Fuji
Queensland Health
Cerilliant
Merck
Colorcon
QuintilesIMS

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