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Serving leading biopharmaceutical companies globally:

Harvard Business School
US Department of Justice

Generated: December 11, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074818

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NDA 074818 describes ESTAZOLAM, which is a drug marketed by Mayne Pharma, Par Pharm, and Watson Labs, and is included in three NDAs. It is available from four suppliers. Additional details are available on the ESTAZOLAM profile page.

The generic ingredient in ESTAZOLAM is estazolam. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estazolam profile page.

Summary for 074818

Formulation / Manufacturing:see details

Pharmacology for NDA: 074818


Medical Subject Heading (MeSH) Categories for 074818

Suppliers and Packaging for NDA: 074818

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTAZOLAM estazolam TABLET;ORAL 074818 ANDA Actavis Pharma, Inc. 0591-0744 0591-0744-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0744-01)
ESTAZOLAM estazolam TABLET;ORAL 074818 ANDA Actavis Pharma, Inc. 0591-0745 0591-0745-01 100 TABLET in 1 BOTTLE, PLASTIC (0591-0745-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Aug 19, 1997TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Aug 19, 1997TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Fish and Richardson
Express Scripts

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