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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074342

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NDA 074342 describes ALPRAZOLAM, which is a drug marketed by Sandoz, West-ward Pharms Int, Roxane, Mylan, Ani Pharms Inc, Natco Pharma Ltd, Apotex Inc, Vintage Pharms, Actavis Elizabeth, Aurobindo Pharma Ltd, Mylan Pharms Inc, Watson Labs, Impax Labs, Anchen Pharms, Dava Intl Inc, Sandoz Inc, Sun Pharma Global, Amneal Pharms Ny, Par Pharm, Heritage Pharms Inc, Vintage, Ivax Sub Teva Pharms, Impax Labs Inc, and Actavis Labs Fl Inc, 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 NDA: 074342

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

Pharmacology for NDA: 074342

Ingredient-typeBenzodiazepines

Suppliers and Packaging for NDA: 074342

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ALPRAZOLAM
alprazolam
TABLET;ORAL 074342 ANDA KAISER FOUNDATION HOSPITALS 0179-0093 0179-0093-30 30 TABLET in 1 BOTTLE (0179-0093-30)
ALPRAZOLAM
alprazolam
TABLET;ORAL 074342 ANDA KAISER FOUNDATION HOSPITALS 0179-0093 0179-0093-50 50 TABLET in 1 BOTTLE (0179-0093-50)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.25MG
Approval Date:Oct 31, 1993TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Oct 31, 1993TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 31, 1993TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Chubb
Julphar
Mallinckrodt
UBS
Queensland Health
Cantor Fitzgerald
Teva
Baxter
Deloitte

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