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Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203346

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NDA 203346 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 203346

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

Pharmacology for NDA: 203346

Ingredient-typeBenzodiazepines

Medical Subject Heading (MeSH) Categories for 203346

Suppliers and Packaging for NDA: 203346

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM alprazolam TABLET;ORAL 203346 ANDA Rising Pharmaceuticals, Inc. 64980-396 64980-396-10 1000 TABLET in 1 BOTTLE (64980-396-10)
ALPRAZOLAM alprazolam TABLET;ORAL 203346 ANDA Rising Pharmaceuticals, Inc. 64980-396 64980-396-01 100 TABLET in 1 BOTTLE (64980-396-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Jul 31, 2015TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jul 31, 2015TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 31, 2015TE:ABRLD:No


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