Application 076457

Type: ANDA
Sponsor: RANBAXY LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GANCICLOVIR	GANCICLOVIR	CAPSULE;ORAL	250MG	No	No
002	GANCICLOVIR	GANCICLOVIR	CAPSULE;ORAL	500MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A076457-001	GANCICLOVIR	GANCICLOVIR	250MG	CAPSULE / ORAL			2003-06-27
A076457-002	GANCICLOVIR	GANCICLOVIR	500MG	CAPSULE / ORAL			2003-06-27

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 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076457-001	GANCICLOVIR	250MG	CAPSULE / ORAL	2003-06-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076457-002	GANCICLOVIR	500MG	CAPSULE / ORAL	2003-06-27	`782e0a99824c…`

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 · 8 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 SODIUM	Fresenius Kabi USA, LLC	b47f5d1c-36b8-49b6-a410-3b3f4661dde7	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ganciclovir
Ganciclovir	GANCICLOVIR SODIUM	Fresenius Kabi USA, LLC	35addab5-09db-4f8a-9c69-6fbce33ecc37	2026-01-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ganciclovir
Ganciclovir	GANCICLOVIR SODIUM	Hikma Pharmaceuticals USA Inc.	4f8219ca-6780-4131-8962-9c3fdd0a84dd	2025-02-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ganciclovir
ganciclovir	GANCICLOVIR SODIUM	Slate Run Pharmaceuticals, LLC	eb100366-2a64-4742-af11-6177a8a494c8	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ganciclovir
Ganciclovir	GANCICLOVIR SODIUM	Pharmascience Inc.	3059c2da-d4a7-4aea-828c-20e671cb875c	2022-12-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ganciclovir
Ganciclovir	GANCICLOVIR	Endo USA, Inc.	87afd103-6e64-444f-971d-0e732e9ae995	2020-12-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Ganciclovir generic name: GANCICLOVIR
ganciclovir	GANCICLOVIR SODIUM	Sagent Pharmaceuticals	993151ed-cea7-49a7-a967-fac3e9b3c85f	2020-11-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ganciclovir

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-636	GANCICLOVIR	GANCICLOVIR	Ranbaxy Pharmaceuticals Inc.	ANDA	Current
63304-637	GANCICLOVIR	GANCICLOVIR	Ranbaxy Pharmaceuticals Inc.	ANDA	Current