Application 210568

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	TABLET;ORAL	EQ 100MG BASE	No	No
002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	TABLET;ORAL	EQ 200MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A210568-001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB		2022-05-18
A210568-002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB		2022-05-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210568-001	AB
A210568-002	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 · 58 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
2026-02-19 14:30 UTC	2026-02	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2022-05-18	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2022-05-18	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210568-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210568-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210568-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210568-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210568-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210568-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210568-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210568-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210568-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210568-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210568-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210568-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210568-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210568-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210568-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210568-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210568-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210568-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210568-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210568-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210568-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A210568-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210568-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A210568-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210568-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210568-002	AB	1	`9b2671bbb829…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	REMEDYREPACK INC.	dae9cbf2-65b5-49fa-898b-924c39b86c57	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Golden State Medical Supply, Inc.	fb313728-09f1-aff8-e053-6394a90a30a8	2025-02-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	fe827f61-9336-72e7-e053-6394a90af75f	2025-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	1b405104-650b-c8e3-e063-6294a90a9e8a	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Amici Pharmaceuticals, LLC.	9d6d7f50-9838-47e3-8214-53e2dbeeadea	2023-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568 ndc (product): 69292-516 ndc (product): 69292-514
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	ce5646cb-a450-4c2c-8499-6ecf71b12b0e	2023-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	5d5ca5b6-282b-4683-908c-854782255739	2022-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210568 application number: ANDA210568 ndc (product): 67877-559 ndc (product): 67877-560

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67877-559	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Ascend Laboratories, LLC	ANDA	Current
67877-560	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Ascend Laboratories, LLC	ANDA	Current
69292-510	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Amici Pharmaceuticals, LLC.	ANDA	Current
69292-512	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Amici Pharmaceuticals, LLC.	ANDA	Current
69292-514	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Amici Pharmaceuticals, LLC.	ANDA	Current
69292-516	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Amici Pharmaceuticals, LLC.	ANDA	Current