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Details for New Drug Application (NDA): 020569

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NDA 020569 describes VITRASERT, which is a drug marketed by Bausch And Lomb and is included in one NDA. Additional details are available on the VITRASERT profile page.

The generic ingredient in VITRASERT is ganciclovir. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the ganciclovir profile page.

Summary for NDA: 020569

Tradename:
VITRASERT
Applicant:
Bausch And Lomb
Ingredient:
ganciclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:IMPLANT;IMPLANTATIONStrength4.5MG
Approval Date:Mar 4, 1996TE:RLD:No

Expired Orange Book Patents for NDA: 020569

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb
VITRASERT
ganciclovir
IMPLANT;IMPLANTATION020569-001Mar 4, 19965,378,475<disabled>
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