Application 213001

Type: ANDA
Sponsor: GLAND PHARMA LTD

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

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213001-001	FOSCARNET SODIUM	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP		2021-04-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213001-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A213001-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213001-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213001-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213001-001	FOSCARNET SODIUM	2.4GM/100ML	INJECTABLE / INJECTION	AP	2021-04-21	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213001-001	FOSCARNET SODIUM	6GM/250ML (24MG/ML)	SOLUTION / INTRAVENOUS	AP	2021-04-21	`a50c72e98297…`

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	A213001-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213001-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213001-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213001-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213001-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213001-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213001-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213001-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213001-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213001-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213001-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213001-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213001-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213001-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213001-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213001-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213001-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213001-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213001-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213001-001	AP	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213001-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213001-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213001-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213001-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213001-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213001-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213001-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213001-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213001-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213001-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213001-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213001-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213001-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213001-001	AP	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213001-001	CGT	2021-12-28	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOSCARNET SODIUM	FOSCARNET SODIUM	Baxter Healthcare Corporation	8a7caffd-9d8a-4d45-ad48-70d511a89c29	2023-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213001 application number: ANDA213001
Foscarnet Sodium	FOSCARNET SODIUM	Gland Pharma Limited	d4048736-389f-48d8-aadd-6bc76d604ddb	2021-04-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213001 application number: ANDA213001 ndc (product): 68083-389
Foscarnet Sodium	FOSCARNET SODIUM	Sagent Pharmaceuticals	2f49c1bc-0828-4e5c-a3c0-81e997213b0e	2021-04-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213001 application number: ANDA213001 ndc (product): 25021-189

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
25021-189	Foscarnet Sodium	Foscarnet Sodium	Sagent Pharmaceuticals	ANDA	Current
68083-389	Foscarnet Sodium	Foscarnet Sodium	Gland Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
67426	ORIG	2021-05-06