Application 050665

Type: NDA
Sponsor: CORDEN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFZIL	CEFPROZIL	FOR SUSPENSION;ORAL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	CEFZIL	CEFPROZIL	FOR SUSPENSION;ORAL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N050665-001	CEFZIL	CEFPROZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1991-12-23
N050665-002	CEFZIL	CEFPROZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL		RLD	1991-12-23

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050665-001	CEFZIL	125MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050665-002	CEFZIL	250MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	FOR SUSPENSION / ORAL	RLD	1991-12-23	`3a93d1ddd44b…`

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 · 13 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	Name fallback generic name: CEFPROZIL
CEFPROZIL	CEFPROZIL	Lupin Pharmaceuticals, Inc.	800a2ec0-4798-4423-9613-d03024cf1f0e	2026-05-04	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
CEFPROZIL	CEFPROZIL	Lupin Pharmaceuticals, Inc.	3ec55c0a-1456-412e-972f-352b3135c8f2	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
CEFPROZIL	CEFPROZIL	Lupin Pharmaceuticals, Inc.	14527f4a-ce99-449d-a5a5-9edd7fb28dee	2025-10-10	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	Ascend Laboratories, LLC	dc3e9cae-6f4f-4045-a11e-2fbf7f94c3c0	2025-05-30	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	A-S Medication Solutions	d5d28d57-1f3c-4c80-ad78-0f67635f5428	2025-01-30	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	Rising Pharma Holdings, Inc.	d7fac9cc-30e1-4762-a01b-04f1bd3b2a56	2024-05-18	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	Aurobindo Pharma Limited	97675251-70b8-43bc-93ea-f9ef6bb8cb68	2024-05-18	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	NorthStar Rx LLC	6133611e-19c1-4df2-8c23-8573aaf63020	2024-05-05	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	Aurobindo Pharma Limited	b9111a81-07c4-4458-b994-a4ad504986d8	2024-05-05	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	Rising Pharma Holdings, Inc.	af24a86f-8072-49a6-94ec-2f17fe81812b	2024-05-05	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	A-S Medication Solutions	8e292a8d-9fd6-45fb-8fb5-d8cb25a4b46d	2024-01-26	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL
Cefprozil	CEFPROZIL	Teva Pharmaceuticals USA, Inc.	3391de8b-7bc9-4624-a5c4-836135b39d99	2018-08-31	Warnings, Adverse reactions	Name fallback generic name: CEFPROZIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
45975	SUPPL	2016-12-01
45953	SUPPL	2016-11-23
7957	SUPPL	2007-09-25
17994	SUPPL	2007-09-19
39082	SUPPL	2004-06-25
30247	SUPPL	2004-06-25
7956	SUPPL	2004-06-09