Application 210574

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFIXIME	CEFIXIME	CAPSULE;ORAL	400MG	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
A210574-001	CEFIXIME	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210574-001	AB

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 · 42 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	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL		RS	2018-10-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210574-001	CEFIXIME	400MG	CAPSULE / ORAL	AB		2018-10-09	`e64feba35796…`

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	A210574-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210574-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210574-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210574-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210574-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210574-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210574-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210574-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210574-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210574-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210574-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210574-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210574-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210574-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210574-001	AB	1	`8072bd15b7f6…`
2019-12-13 00:20 UTC	2019-12	A210574-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A210574-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210574-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210574-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210574-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210574-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210574-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210574-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210574-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210574-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210574-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210574-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210574-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210574-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210574-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210574-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210574-001	AB	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFIXIME	CEFIXIME	REMEDYREPACK INC.	d6718f02-8eea-4c2f-9aa2-65121d9a6e4c	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210574 application number: ANDA210574 ndc (product): 70518-2749
Cefixime 400 mg	CEFIXIME	Health Department, Oklahoma State	f0fdb14b-e4fb-707e-e053-2a95a90a9049	2025-12-20	Warnings	Exact identifier application applno (ANDA): 210574 application number: ANDA210574
CEFIXIME	CEFIXIME	Ascend Laboratories, LLC	6f1df975-f825-4301-87da-d7eba56a6890	2022-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210574 application number: ANDA210574 ndc (product): 67877-584

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-584	CEFIXIME	CEFIXIME	Ascend Laboratories, LLC	ANDA	Current
67877-584	CEFIXIME	CEFIXIME	Ascend Laboratories, LLC	ANDA	Current
67877-584	CEFIXIME	CEFIXIME	Ascend Laboratories, LLC	ANDA	Current
70518-2749	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	ANDA	Current
70518-2749	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	ANDA	Current
70518-2749	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	ANDA	Current
70518-2749	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	ANDA	Current
70518-2749	CEFIXIME	CEFIXIME	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56478	ORIG	2018-11-15