Application 065381

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFPROZIL	CEFPROZIL	FOR SUSPENSION;ORAL	125MG/5ML	No	No
002	CEFPROZIL	CEFPROZIL	FOR SUSPENSION;ORAL	250MG/5ML	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
A065381-001	CEFPROZIL	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB		2007-01-30
A065381-002	CEFPROZIL	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB		2007-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065381-001	AB
A065381-002	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	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065381-001	CEFPROZIL	125MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065381-002	CEFPROZIL	250MG/5ML	FOR SUSPENSION / ORAL	AB	2007-01-30	`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	A065381-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065381-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065381-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065381-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065381-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065381-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065381-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065381-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065381-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065381-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065381-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065381-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065381-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065381-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065381-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065381-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065381-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065381-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065381-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065381-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065381-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065381-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065381-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065381-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065381-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065381-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065381-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065381-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065381-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065381-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065381-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065381-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065381-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065381-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065381-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065381-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065381-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065381-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065381-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065381-002	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	NorthStar Rx LLC	8e3943b5-8c30-4c81-bcfa-aeaaa1d75fb4	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381 ndc (product): 16714-396 ndc (product): 16714-397
Cefprozil	CEFPROZIL	Rising Pharma Holdings, Inc.	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	2024-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381 ndc (product): 57237-035 ndc (product): 57237-034
Cefprozil	CEFPROZIL	Aurobindo Pharma Limited	97675251-70b8-43bc-93ea-f9ef6bb8cb68	2024-05-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381 ndc (product): 65862-099 ndc (product): 65862-100
Cefprozil	CEFPROZIL	A-S Medication Solutions	8e292a8d-9fd6-45fb-8fb5-d8cb25a4b46d	2024-01-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065381 application number: ANDA065381 ndc (product): 50090-3226

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-396	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-396	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-396	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-397	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-397	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
16714-397	Cefprozil	Cefprozil	NorthStar Rx LLC	ANDA	Current
50090-3226	Cefprozil	Cefprozil	A-S Medication Solutions	ANDA	Current
57237-034	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-034	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-034	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-035	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-035	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
57237-035	Cefprozil	Cefprozil	Rising Health, LLC	ANDA	Current
65862-099	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-099	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-099	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-100	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-100	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current
65862-100	Cefprozil	Cefprozil	Aurobindo Pharma Limited	ANDA	Current