Application 090031

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	FOR SUSPENSION;ORAL	EQ 50MG BASE/5ML	No	No
002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	FOR SUSPENSION;ORAL	EQ 100MG BASE/5ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A090031-001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL			2009-01-14
A090031-002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL			2009-01-14

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090031-001	CEFPODOXIME PROXETIL	EQ 50MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090031-002	CEFPODOXIME PROXETIL	EQ 100MG BASE/5ML	FOR SUSPENSION / ORAL	2009-01-14	`74a2ff9319b5…`

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 brand name: CEFPODOXIME PROXETIL generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Sandoz Inc	8519a9d8-7106-4545-bc58-859ee9a6708e	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	REMEDYREPACK INC.	dae9cbf2-65b5-49fa-898b-924c39b86c57	2026-06-04	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil 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 brand name: Cefpodoxime Proxetil 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 brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	fe827f61-9336-72e7-e053-6394a90af75f	2025-02-06	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	1b405104-650b-c8e3-e063-6294a90a9e8a	2024-06-19	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: CEFPODOXIME PROXETIL generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	NorthStar Rx LLC	5310de78-22c3-4bee-9956-854e767b6bef	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	63777889-d306-4fc3-88da-b24859040ef4	2024-01-04	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	c36f2137-98bb-4583-89f7-6bce9582c465	2024-01-03	Warnings, Adverse reactions	Name fallback brand name: CEFPODOXIME PROXETIL generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9	2024-01-03	Warnings, Adverse reactions	Name fallback brand name: CEFPODOXIME PROXETIL generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Amici Pharmaceuticals, LLC.	9d6d7f50-9838-47e3-8214-53e2dbeeadea	2023-07-13	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	ce5646cb-a450-4c2c-8499-6ecf71b12b0e	2023-04-14	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL
Cefpodoxime Proxetil	CEFPODOXIME PROXETIL	Ascend Laboratories, LLC	5d5ca5b6-282b-4683-908c-854782255739	2022-05-20	Warnings, Adverse reactions	Name fallback brand name: Cefpodoxime Proxetil generic name: CEFPODOXIME PROXETIL

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-6168	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Sandoz Inc	ANDA	Current
0781-6169	Cefpodoxime Proxetil	Cefpodoxime Proxetil	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39607	SUPPL	2014-07-30
31441	SUPPL	2014-07-24