Application 065370

Type: ANDA
Sponsor: AUROBINDO PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	TABLET;ORAL	EQ 100MG BASE	No	No
002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	TABLET;ORAL	EQ 200MG BASE	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
A065370-001	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB		2007-06-11
A065370-002	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB		2007-06-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A065370-001	AB
A065370-002	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	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065370-001	CEFPODOXIME PROXETIL	EQ 100MG BASE	TABLET / ORAL	AB	2007-06-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065370-002	CEFPODOXIME PROXETIL	EQ 200MG BASE	TABLET / ORAL	AB	2007-06-11	`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	A065370-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A065370-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A065370-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A065370-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A065370-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A065370-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A065370-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A065370-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A065370-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A065370-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A065370-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A065370-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A065370-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A065370-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A065370-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A065370-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A065370-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A065370-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A065370-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A065370-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A065370-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A065370-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A065370-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A065370-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A065370-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A065370-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A065370-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A065370-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A065370-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	bc9c338c-1fc7-4bc2-a357-a78e433cbe9d	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370 ndc (product): 69043-007 ndc (product): 69043-006
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	c36f2137-98bb-4583-89f7-6bce9582c465	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370 ndc (product): 65862-095 ndc (product): 65862-096
CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	4587a7c1-cd6c-4946-a0dd-fcfe0c8504b9	2024-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 065370 application number: ANDA065370 ndc (product): 16714-394 ndc (product): 16714-395

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-394	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-394	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-394	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-394	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-395	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-395	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-395	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
16714-395	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NorthStar Rx LLC	ANDA	Current
52343-019	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Gen-Source Rx	ANDA	Current
52343-020	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Gen-Source Rx	ANDA	Current
55289-393	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	PD-Rx Pharmaceuticals, In	ANDA	Current
55289-393	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-393	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-393	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-393	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55289-393	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
65862-095	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	ANDA	Current
65862-095	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	ANDA	Current
65862-095	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	ANDA	Current
65862-096	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	ANDA	Current
65862-096	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	ANDA	Current
65862-096	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Aurobindo Pharma Limited	ANDA	Current
68071-2742	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	NuCare Pharmaceuticals,Inc.	ANDA	Current
69043-006	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	ANDA	Current
69043-006	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	ANDA	Current
69043-006	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	ANDA	Current
69043-007	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	ANDA	Current
69043-007	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	ANDA	Current
69043-007	CEFPODOXIME PROXETIL	CEFPODOXIME PROXETIL	Cronus Pharma LLC	ANDA	Current