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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
US Department of Justice
Boehringer Ingelheim
Accenture
Covington
US Army
Chubb
Cantor Fitzgerald
Baxter

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020623

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NDA 020623 describes ANZEMET, which is a drug marketed by Us Pharm Holdings and is included in two NDAs. It is available from two suppliers. Additional details are available on the ANZEMET profile page.

The generic ingredient in ANZEMET is dolasetron mesylate. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the dolasetron mesylate profile page.
Summary for 020623
Tradename:ANZEMET
Applicant:Us Pharm Holdings
Ingredient:dolasetron mesylate
Patents:0
Therapeutic Class:Antiemetics
Formulation / Manufacturing:see details
Pharmacology for NDA: 020623
Suppliers and Packaging for NDA: 020623
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ANZEMET dolasetron mesylate TABLET;ORAL 020623 NDA Validus Pharmaceuticals LLC 30698-120 E 30698-120-05
ANZEMET dolasetron mesylate TABLET;ORAL 020623 NDA Validus Pharmaceuticals LLC 30698-121 E 30698-121-05

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Sep 11, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength100MG
Approval Date:Sep 11, 1997TE:RLD:Yes

Expired US Patents for NDA 020623

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Us Pharm Holdings ANZEMET dolasetron mesylate TABLET;ORAL 020623-002 Sep 11, 1997 ➤ Sign Up ➤ Sign Up
Us Pharm Holdings ANZEMET dolasetron mesylate TABLET;ORAL 020623-001 Sep 11, 1997 ➤ Sign Up ➤ Sign Up
Us Pharm Holdings ANZEMET dolasetron mesylate TABLET;ORAL 020623-002 Sep 11, 1997 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Johnson and Johnson
Baxter
QuintilesIMS
Chinese Patent Office
Julphar
Cantor Fitzgerald
Argus Health
Merck

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