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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 020624


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NDA 020624 describes ANZEMET, which is a drug marketed by Validus Pharms and is included in two NDAs. It is available from one supplier. Additional details are available on the ANZEMET profile page.

The generic ingredient in ANZEMET is dolasetron mesylate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolasetron mesylate profile page.
Summary for 020624
Tradename:ANZEMET
Applicant:Validus Pharms
Ingredient:dolasetron mesylate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100MG/5ML (20MG/ML)
Approval Date:Sep 11, 1997TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength12.5MG/0.625ML (20MG/ML)
Approval Date:Sep 11, 1997TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength500MG/25ML (20MG/ML)
Approval Date:Dec 11, 2001TE:RLD:No

Expired US Patents for NDA 020624

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Validus Pharms ANZEMET dolasetron mesylate INJECTABLE;INJECTION 020624-002 Sep 11, 1997 ⤷  Try a Trial ⤷  Try a Trial
Validus Pharms ANZEMET dolasetron mesylate INJECTABLE;INJECTION 020624-003 Dec 11, 2001 ⤷  Try a Trial ⤷  Try a Trial
Validus Pharms ANZEMET dolasetron mesylate INJECTABLE;INJECTION 020624-001 Sep 11, 1997 ⤷  Try a Trial ⤷  Try a Trial
Validus Pharms ANZEMET dolasetron mesylate INJECTABLE;INJECTION 020624-001 Sep 11, 1997 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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