Home Applications 065462 Application 065462
Type ANDA
Sponsor SANDOZ 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 Yes
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 A065462-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 A065462-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065462-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2008-05-28 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065462-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB RS 2008-05-28 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0781-5438 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5438 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5438 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5438 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5439 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5439 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5439 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 0781-5439 Cefpodoxime Proxetil Cefpodoxime Proxetil Sandoz Inc ANDA Current 26637-711 Cefpodoxime Proxetil Cefpodoxime Proxetil Putney Inc ANDA Current 26637-712 Cefpodoxime Proxetil Cefpodoxime Proxetil Putney Inc ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 30665 SUPPL 2014-02-24 18339 SUPPL 2014-02-20