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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074921

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NDA 074921 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 three 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. Three suppliers are listed for this compound. Additional details are available on the estazolam profile page.
Summary for 074921
Applicant:Mayne Pharma
Formulation / Manufacturing:see details
Pharmacology for NDA: 074921
Medical Subject Heading (MeSH) Categories for 074921
Suppliers and Packaging for NDA: 074921
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESTAZOLAM estazolam TABLET;ORAL 074921 ANDA Mayne Pharma 51862-069 N 51862-069-01
ESTAZOLAM estazolam TABLET;ORAL 074921 ANDA Mayne Pharma 51862-070 N 51862-070-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jul 10, 1997TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2MG
Approval Date:Jul 10, 1997TE:ABRLD:No

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Chinese Patent Office
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