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Medtronic
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Generated: April 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078387

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NDA 078387 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-one 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-three suppliers are listed for this compound. Additional details are available on the alprazolam profile page.
Summary for 078387
Tradename:ALPRAZOLAM
Applicant:Amneal Pharms Ny
Ingredient:alprazolam
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078387
Ingredient-typeBenzodiazepines
Medical Subject Heading (MeSH) Categories for 078387
Suppliers and Packaging for NDA: 078387
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078387 ANDA Rebel Distributors Corp. 21695-602 E 21695-602-60
ALPRAZOLAM alprazolam TABLET, EXTENDED RELEASE;ORAL 078387 ANDA Rebel Distributors Corp. 21695-603 E 21695-603-60

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength0.5MG
Approval Date:May 30, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength1MG
Approval Date:May 30, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, EXTENDED RELEASE;ORALStrength2MG
Approval Date:May 30, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
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US Department of Justice
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