Application 065340

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFPROZIL	CEFPROZIL	TABLET;ORAL	250MG	No	No
002	CEFPROZIL	CEFPROZIL	TABLET;ORAL	500MG	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
A065340-001	CEFPROZIL	CEFPROZIL	250MG	TABLET / ORAL	AB		2007-05-24
A065340-002	CEFPROZIL	CEFPROZIL	500MG	TABLET / ORAL	AB		2007-05-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065340-001	AB
A065340-002	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	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065340-001	CEFPROZIL	250MG	TABLET / ORAL	AB	2007-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065340-002	CEFPROZIL	500MG	TABLET / ORAL	AB	2007-05-24	`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	A065340-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065340-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065340-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065340-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065340-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065340-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065340-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065340-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065340-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065340-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065340-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065340-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065340-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065340-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065340-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065340-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065340-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065340-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065340-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065340-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065340-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065340-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065340-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065340-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065340-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065340-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065340-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065340-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065340-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Cefprozil	CEFPROZIL	A-S Medication Solutions	d5d28d57-1f3c-4c80-ad78-0f67635f5428	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340 ndc (product): 50090-1710
Cefprozil	CEFPROZIL	NorthStar Rx LLC	6133611e-19c1-4df2-8c23-8573aaf63020	2024-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340 ndc (product): 16714-398 ndc (product): 16714-399
Cefprozil	CEFPROZIL	Aurobindo Pharma Limited	b9111a81-07c4-4458-b994-a4ad504986d8	2024-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340 ndc (product): 65862-068 ndc (product): 65862-069
Cefprozil	CEFPROZIL	Rising Pharma Holdings, Inc.	af24a86f-8072-49a6-94ec-2f17fe81812b	2024-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065340 application number: ANDA065340 ndc (product): 57237-037 ndc (product): 57237-036

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-398	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-398	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-398	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-399	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-399	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-399	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
50090-1710	Cefprozil	Cefprozil	A-S Medication Solutions	ANDA	Current
50090-1739	Cefprozil	Cefprozil	A-S Medication Solutions	ANDA	Current
50090-1739	Cefprozil	Cefprozil	A-S Medication Solutions	ANDA	Current
55700-294	Cefprozil	Cefprozil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-294	Cefprozil	Cefprozil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-294	Cefprozil	Cefprozil	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
57237-036	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-036	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-036	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-037	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-037	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-037	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
65862-068	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-068	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-068	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-069	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-069	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-069	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
67296-1180	Cefprozil	Cefprozil	RedPharm Drug, Inc.	ANDA	Current
67296-1180	Cefprozil	Cefprozil	RedPharm Drug, Inc.	ANDA	Current
67296-1180	Cefprozil	Cefprozil	RedPharm Drug, Inc.	ANDA	Current