Application 077174

Type: ANDA
Sponsor: HOSPIRA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSCARNET SODIUM	FOSCARNET SODIUM	INJECTABLE;INJECTION	2.4GM/100ML	No	No
002	FOSCARNET SODIUM	FOSCARNET SODIUM	SOLUTION;INTRAVENOUS	12GM/500ML (24MG/ML)	No	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
A077174-001	FOSCARNET SODIUM	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS			2005-05-31
A077174-002	FOSCARNET SODIUM	FOSCARNET SODIUM	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS			2005-05-31

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077174-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077174-002	FOSCARNET SODIUM	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077174-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077174-002	FOSCARNET SODIUM	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077174-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077174-002	FOSCARNET SODIUM	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077174-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077174-002	FOSCARNET SODIUM	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS	2005-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077174-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	2005-05-31	`3f0d92c62455…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Foscarnet Sodium	FOSCARNET SODIUM	Amneal Pharmaceuticals LLC	b03cbb8e-f555-4ed3-854e-dd962604f144	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Foscarnet Sodium generic name: FOSCARNET SODIUM
Foscarnet Sodium	FOSCARNET SODIUM	Caplin Steriles Limited	6ec3bb2a-fb40-4d4a-bc1b-feea80cc1a95	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Foscarnet Sodium generic name: FOSCARNET SODIUM
Foscavir	FOSCARNET SODIUM	Clinigen Limited	a09299d5-9c55-4cef-aed0-3a6a45532289	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FOSCARNET SODIUM
Foscavir	FOSCARNET SODIUM	Clinigen Limited	90e3da4e-3b1f-428b-99ca-e4bed1c80028	2025-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FOSCARNET SODIUM
foscarnet sodium	FOSCARNET SODIUM	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	d2b4ce68-5a81-4b14-8914-21bc38f01008	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: foscarnet sodium generic name: FOSCARNET SODIUM
Foscarnet Sodium	FOSCARNET SODIUM	Hikma Pharmaceuticals USA Inc.	b612e6f1-584f-4188-b96e-1a9adfcfe75c	2024-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Foscarnet Sodium generic name: FOSCARNET SODIUM
FOSCARNET SODIUM	FOSCARNET SODIUM	Baxter Healthcare Corporation	8a7caffd-9d8a-4d45-ad48-70d511a89c29	2023-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: FOSCARNET SODIUM generic name: FOSCARNET SODIUM
Foscarnet	FOSCARNET SODIUM	Fresenius Kabi USA, LLC	335f7deb-a045-43cb-b319-d7b73bfda73c	2021-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: FOSCARNET SODIUM
Foscarnet Sodium	FOSCARNET SODIUM	Gland Pharma Limited	d4048736-389f-48d8-aadd-6bc76d604ddb	2021-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Foscarnet Sodium generic name: FOSCARNET SODIUM
Foscarnet Sodium	FOSCARNET SODIUM	Sagent Pharmaceuticals	2f49c1bc-0828-4e5c-a3c0-81e997213b0e	2021-04-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Foscarnet Sodium generic name: FOSCARNET SODIUM

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
9015	ORIG	2005-06-07