Application 210124

Type: ANDA
Sponsor: GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUOROURACIL	FLUOROURACIL	INJECTABLE;INJECTION	2.5GM/50ML (50MG/ML)	No	No
002	FLUOROURACIL	FLUOROURACIL	INJECTABLE;INJECTION	5GM/100ML (50MG/ML)	No	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
A210124-001	FLUOROURACIL	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP		2017-12-26
A210124-002	FLUOROURACIL	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP		2017-12-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210124-001	AP
A210124-002	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 3 · 84 observed 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	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210124-001	FLUOROURACIL	2.5GM/50ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210124-002	FLUOROURACIL	5GM/100ML (50MG/ML)	INJECTABLE / INJECTION	AP	2017-12-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210124-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210124-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210124-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210124-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210124-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210124-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210124-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210124-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210124-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210124-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210124-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210124-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210124-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210124-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210124-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210124-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210124-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210124-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210124-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210124-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210124-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210124-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210124-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210124-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210124-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210124-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210124-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210124-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A210124-002	AP	1	`bb7c543d1eb4…`

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
Fluorouracil	FLUOROURACIL	BluePoint Laboratories	300304fa-4791-4455-962c-493ae467f504	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210124 application number: ANDA210124 ndc (product): 68001-525
Fluorouracil	FLUOROURACIL	Xiromed LLC	f4b0cae1-a2fc-2991-d663-3b729503cd1c	2026-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210124 application number: ANDA210124 ndc (product): 70700-188 ndc (product): 70700-189
Fluorouracil	FLUOROURACIL	Gland Pharma Limited	ea3497db-23b9-4ace-9a6f-b54853d04a82	2025-11-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210124 application number: ANDA210124 ndc (product): 68083-292 ndc (product): 68083-293

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68001-525	Fluorouracil	Fluorouracil	BluePoint Laboratories	ANDA	Current
68083-292	Fluorouracil	Fluorouracil	Gland Pharma Limited	ANDA	Current
68083-292	Fluorouracil	Fluorouracil	Gland Pharma Limited	ANDA	Current
68083-293	Fluorouracil	Fluorouracil	Gland Pharma Limited	ANDA	Current
68083-293	Fluorouracil	Fluorouracil	Gland Pharma Limited	ANDA	Current
70700-188	Fluorouracil	Fluorouracil	Xiromed LLC	ANDA	Current
70700-189	Fluorouracil	Fluorouracil	Xiromed LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85254	SUPPL	2026-03-03
85236	SUPPL	2026-03-03
77984	SUPPL	2024-03-27
77977	SUPPL	2024-03-26