Application 050674

Type: NDA
Sponsor: PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VANTIN	CEFPODOXIME PROXETIL	TABLET;ORAL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	VANTIN	CEFPODOXIME PROXETIL	TABLET;ORAL	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N050674-001	VANTIN	CEFPODOXIME PROXETIL	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-08-07
N050674-002	VANTIN	CEFPODOXIME PROXETIL	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-08-07

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UTC	2019-12	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-08-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050674-001	VANTIN	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N050674-002	VANTIN	EQ 200MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-08-07	`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 · 15 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Redpharm Drug	59d848e9-de7a-669b-e063-6394a90a2b35	2026-08-25	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Sandoz Inc	8519a9d8-7106-4545-bc58-859ee9a6708e	2026-07-30	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	REMEDYREPACK INC.	dae9cbf2-65b5-49fa-898b-924c39b86c57	2026-06-04	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Rising Pharma Holdings, Inc.	edf589b2-f796-4522-a5e6-2bd0a833922f	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Golden State Medical Supply, Inc.	fb313728-09f1-aff8-e053-6394a90a30a8	2025-02-18	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	fe827f61-9336-72e7-e053-6394a90af75f	2025-02-06	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	1b405104-650b-c8e3-e063-6294a90a9e8a	2024-06-19	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NorthStar Rx LLC	5310de78-22c3-4bee-9956-854e767b6bef	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	63777889-d306-4fc3-88da-b24859040ef4	2024-01-04	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	c36f2137-98bb-4583-89f7-6bce9582c465	2024-01-03	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9	2024-01-03	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Amici Pharmaceuticals, LLC.	9d6d7f50-9838-47e3-8214-53e2dbeeadea	2023-07-13	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	ce5646cb-a450-4c2c-8499-6ecf71b12b0e	2023-04-14	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	5d5ca5b6-282b-4683-908c-854782255739	2022-05-20	Warnings, Adverse reactions	Name fallback generic name: CEFPODOXIME PROXETIL

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
39093	SUPPL	2013-06-25
30259	SUPPL	2013-06-24
30258	SUPPL	2007-06-07
18003	SUPPL	2007-06-07
39092	SUPPL	2004-06-07
7970	SUPPL	2004-06-07
22177	SUPPL	1998-11-20
7969	SUPPL	1998-11-20