Application 020068

Type: NDA
Sponsor: CLINIGEN HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FOSCAVIR	FOSCARNET SODIUM	INJECTABLE;INJECTION	2.4GM/100ML	Yes	Yes
002	FOSCAVIR	FOSCARNET SODIUM	SOLUTION;INTRAVENOUS	12GM/500ML (24MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020068-001	FOSCAVIR	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1991-09-27
N020068-002	FOSCAVIR	FOSCARNET SODIUM	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS		RLD	1991-09-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020068-001	AP

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 · 46 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020068-001	FOSCAVIR	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1991-09-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020068-002	FOSCAVIR	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS		RLD	1991-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020068-001	FOSCAVIR	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1991-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020068-002	FOSCAVIR	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS		RLD	1991-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020068-001	FOSCAVIR	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	RLD, RS	1991-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020068-002	FOSCAVIR	12GM/500ML (24MG/ML)	SOLUTION / INTRAVENOUS		RLD	1991-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION		RLD, RS	1991-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION		RLD, RS	1991-09-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION		RLD, RS	1991-09-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION		RLD, RS	1991-09-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION		RLD, RS	1991-09-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION		RLD, RS	1991-09-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020068-001	FOSCAVIR	2.4GM/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1991-09-27	`3bdfa0b2c4d7…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020068-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020068-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020068-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020068-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020068-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020068-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020068-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020068-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020068-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020068-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020068-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020068-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020068-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020068-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020068-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020068-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020068-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020068-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N020068-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020068-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020068-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020068-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020068-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020068-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020068-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020068-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020068-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020068-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020068-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020068-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020068-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020068-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020068-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020068-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020068-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020068-001	AP	1	`a50c72e98297…`

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
Foscavir	FOSCARNET SODIUM	Clinigen Limited	a09299d5-9c55-4cef-aed0-3a6a45532289	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020068 application number: NDA020068 ndc (product): 76310-024
Foscavir	FOSCARNET SODIUM	Clinigen Limited	90e3da4e-3b1f-428b-99ca-e4bed1c80028	2025-12-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020068 application number: NDA020068 ndc (product): 76310-024

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Healthcare Ltd.	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	FOSCARNET SODIUM	Clinigen Limited	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	FOSCARNET SODIUM	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Limited	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Limited	NDA	Current
76310-024	Foscavir	FOSCARNET SODIUM	Clinigen Group PLC	NDA	Current
76310-024	Foscavir	foscarnet sodium	Clinigen Healthcare Ltd.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65488	SUPPL	2020-12-02
65373	SUPPL	2020-11-30
47432	SUPPL	2017-03-02
47336	SUPPL	2017-02-27
45893	SUPPL	2016-11-15
45889	SUPPL	2016-11-14
12177	SUPPL	2015-05-05
21103	SUPPL	2014-11-12
34234	SUPPL	2012-04-06
34233	SUPPL	2007-12-03
21102	SUPPL	2006-05-18
34232	SUPPL	2006-05-16