Application 065496

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 250MG BASE	No	No
002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	TABLET;ORAL	EQ 500MG BASE	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
A065496-001	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB		2010-06-07
A065496-002	CEFUROXIME AXETIL	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB		2010-06-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065496-001	AB
A065496-002	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 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	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065496-001	CEFUROXIME AXETIL	EQ 250MG BASE	TABLET / ORAL	AB	2010-06-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065496-002	CEFUROXIME AXETIL	EQ 500MG BASE	TABLET / ORAL	AB	2010-06-07	`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	A065496-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065496-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065496-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065496-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065496-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065496-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065496-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065496-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065496-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065496-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065496-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065496-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065496-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065496-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065496-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065496-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065496-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065496-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065496-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065496-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065496-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065496-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065496-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065496-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065496-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065496-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065496-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065496-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065496-002	AB	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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefuroxime axetil	CEFUROXIME AXETIL	Golden State Medical Supply, Inc.	bb7955fe-5111-1662-e053-2a95a90a85a1	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 51407-333 ndc (product): 51407-334
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals, Inc.	4e4426a4-0ca9-dad5-e063-6294a90a5fdb	2026-03-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Advanced Rx of Tennessee, LLC	48d96608-d3da-b512-e063-6294a90a07d5	2026-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	Redpharm Drug	3744f28c-c7e1-259c-e063-6294a90a10ed	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af8f061-c0e1-3a1c-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 43063-656
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	2af94304-8118-41c7-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 43063-657
Cefuroxime axetil	CEFUROXIME AXETIL	Ascend Laboratories, LLC	dd11e4b9-7730-4d3a-81ca-16f15de09759	2025-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 67877-215 ndc (product): 67877-216
Cefuroxime axetil	CEFUROXIME AXETIL	Major Pharmaceuticals	44e1fb4d-4b61-40da-9974-0bd2006eb828	2025-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496
Cefuroxime axetil	CEFUROXIME AXETIL	American Health Packaging	f38418a7-dd90-4f20-b747-7ac086c53015	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 60687-272
Cefuroxime axetil	CEFUROXIME AXETIL	PD-Rx Pharmaceuticals, Inc.	15cabe73-f39d-4798-a840-115fe94f8f96	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 72789-035
Cefuroxime axetil	CEFUROXIME AXETIL	A-S Medication Solutions	84593261-838c-433a-8d9d-1d37b11058da	2024-09-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 50090-2159
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	83476d51-be74-748b-e053-2a91aa0a3d36	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 68071-1637
Cefuroxime axetil	CEFUROXIME AXETIL	NuCare Pharmaceuticals,Inc.	8c3c1c85-cbce-66e2-e053-2a95a90a94fe	2024-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 68071-4947
Cefuroxime axetil	CEFUROXIME AXETIL	A-S Medication Solutions	c89e8f4d-96c0-44c6-906a-b803141920b1	2024-02-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 50090-2158 ndc (product): 50090-2157
Cefuroxime axetil	CEFUROXIME AXETIL	Proficient Rx LP	e9a020ec-e446-469a-b1d1-07e82eefa305	2023-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065496 application number: ANDA065496 ndc (product): 63187-991

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 73 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-656	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-657	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-2157	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2157	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2157	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2158	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2158	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2158	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2159	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
50090-2159	Cefuroxime axetil	Cefuroxime axetil	A-S Medication Solutions	ANDA	Current
51407-333	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-333	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-333	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-333	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-334	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-334	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-334	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
51407-334	Cefuroxime axetil	Cefuroxime axetil	Golden State Medical Supply, Inc.	ANDA	Current
52959-308	Cefuroxime axetil	Cefuroxime axetil	H.J. Harkins Company, Inc.	ANDA	Current
53002-2670	Cefuroxime axetil	Cefuroxime axetil	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-2750	Cefuroxime axetil	Cefuroxime axetil	RPK Pharmaceuticals, Inc.	ANDA	Current
55700-655	Cefuroxime axetil	Cefuroxime axetil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-655	Cefuroxime axetil	Cefuroxime axetil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-655	Cefuroxime axetil	Cefuroxime axetil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
60687-272	Cefuroxime axetil	Cefuroxime axetil	American Health Packaging	ANDA	Current
60687-272	Cefuroxime axetil	Cefuroxime axetil	American Health Packaging	ANDA	Current
60687-272	Cefuroxime axetil	Cefuroxime axetil	American Health Packaging	ANDA	Current
60687-272	Cefuroxime axetil	Cefuroxime axetil	American Health Packaging	ANDA	Current
60687-272	Cefuroxime axetil	Cefuroxime axetil	American Health Packaging	ANDA	Current
61919-747	CEFUROXIME AXETIL	CEFUROXIME AXETIL	Direct_Rx	ANDA	Current
61919-747	CEFUROXIME AXETIL	CEFUROXIME AXETIL	Direct_Rx	ANDA	Current
63187-991	Cefuroxime axetil	Cefuroxime axetil	Proficient Rx LP	ANDA	Current
63187-991	Cefuroxime axetil	Cefuroxime axetil	Proficient Rx LP	ANDA	Current
63187-991	Cefuroxime axetil	Cefuroxime axetil	Proficient Rx LP	ANDA	Current
63629-9446	Cefuroxime axetil	Cefuroxime axetil	Bryant Ranch Prepack	ANDA	Current
63629-9447	Cefuroxime axetil	Cefuroxime axetil	Bryant Ranch Prepack	ANDA	Current
63629-9448	Cefuroxime axetil	Cefuroxime axetil	Bryant Ranch Prepack	ANDA	Current
63629-9449	Cefuroxime axetil	Cefuroxime axetil	Bryant Ranch Prepack	ANDA	Current
67877-215	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-215	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-215	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-215	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-216	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-216	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-216	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
67877-216	Cefuroxime axetil	Cefuroxime axetil	Ascend Laboratories, LLC	ANDA	Current
68071-1637	Cefuroxime axetil	Cefuroxime axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1637	Cefuroxime axetil	Cefuroxime axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-1637	Cefuroxime axetil	Cefuroxime axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4947	Cefuroxime axetil	Cefuroxime axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4947	Cefuroxime axetil	Cefuroxime axetil	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-2694	Cefuroxime axetil	Cefuroxime axetil	REMEDYREPACK INC.	ANDA	Current
70518-2694	Cefuroxime axetil	Cefuroxime axetil	REMEDYREPACK INC.	ANDA	Current
70518-2694	Cefuroxime axetil	Cefuroxime axetil	REMEDYREPACK INC.	ANDA	Current
72789-035	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-035	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-035	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-035	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-035	Cefuroxime axetil	Cefuroxime axetil	PD-Rx Pharmaceuticals, Inc.	ANDA	Current