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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078449

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NDA 078449 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 078449
Tradename:ALPRAZOLAM
Applicant:Apotex Inc
Ingredient:alprazolam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078449
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 078449
Suppliers and Packaging for NDA: 078449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078449 ANDA Apotex Corp 60505-2634 N 60505-2634-8
ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078449 ANDA Apotex Corp 60505-2634 N 60505-2634-6

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.5MG
Approval Date:Nov 12, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG
Approval Date:Nov 12, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength3MG
Approval Date:Nov 12, 2008TE:ABRLD:No

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