Application 020460

Type: NDA
Sponsor: ROCHE PALO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CYTOVENE	GANCICLOVIR	CAPSULE;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CYTOVENE	GANCICLOVIR	CAPSULE;ORAL	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020460-001	CYTOVENE	GANCICLOVIR	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1994-12-22
N020460-002	CYTOVENE	GANCICLOVIR	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL		RLD	1997-12-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1994-12-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL	RLD	1997-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020460-001	CYTOVENE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1994-12-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020460-002	CYTOVENE	500MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	CAPSULE / ORAL	RLD	1997-12-12	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZIRGAN	GANCICLOVIR	Bausch & Lomb Incorporated	ea25e7ac-7a93-4ec8-975b-2cec197e1c27	2026-05-18	Warnings, Adverse reactions	Name fallback generic name: GANCICLOVIR
Ganciclovir	GANCICLOVIR	Endo USA, Inc.	87afd103-6e64-444f-971d-0e732e9ae995	2020-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: GANCICLOVIR

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
41378	SUPPL	1997-12-12