Assyro AI

Orange Book product · Brand (NDA)

CYTOVENE

GANCICLOVIR

Brand (NDA)NDA 020460DISCN ROCHE PALO
View GANCICLOVIR familyOpen on FDA Orange Book

At a glance

Dec 12, 1997

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 12, 1997

    28 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GANCICLOVIR

Strength

500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

NDA 020460

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Agent CTA Background

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