FDA Orange Book
Generic for Cytovene
Cytovene contains ganciclovir. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Cytovene is ganciclovir. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Cytovene products the Orange Book lists.
Run it in Rivvi
Map Cytovene and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Cytovene products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 250MG | Discontinued | None | 0 | None |
| capsule, oral | 500MG | Discontinued | None | 0 | None |
| injectable, injection | EQ 500MG BASE/VIAL | Discontinued | None | 5 | AP |
NDA 020460, 019661, held by ROCHE PALO ALTO LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ganciclovir
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| HIKMA PHARMACEUTICALS USA INC | 076222 | AP (A-rated, therapeutically equivalent) | July 16, 2003 | EQ 500MG BASE/VIAL |
| FRESENIUS KABI USA LLC | 090658 | AP (A-rated, therapeutically equivalent) | June 21, 2010 | EQ 500MG BASE/VIAL |
| PH HEALTH LTD | 204950 | AP (A-rated, therapeutically equivalent) | December 6, 2016 | EQ 500MG BASE/VIAL |
| PHARMASCIENCE INC | 207645 | AP (A-rated, therapeutically equivalent) | December 8, 2017 | EQ 500MG BASE/VIAL |
| HAINAN POLY PHARM CO LTD | 204204 | AP (A-rated, therapeutically equivalent) | November 8, 2018 | EQ 500MG BASE/VIAL |
Questions
Is there a generic for Cytovene?
Yes. The generic name for Cytovene is ganciclovir. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 3 Cytovene products the Orange Book lists.
What is the generic name for Cytovene?
The active ingredient in Cytovene is ganciclovir, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.