Home Applications 065388 Application 065388
Type ANDA
Sponsor ORCHID HLTHCARE 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 1 .
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 A065388-001 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 A065388-002 CEFPODOXIME PROXETIL CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14
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 · 82 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 2026-02-19 14:30 UTC 2026-02 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065388-001 CEFPODOXIME PROXETIL EQ 100MG BASE TABLET / ORAL AB 2007-11-14 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065388-002 CEFPODOXIME PROXETIL EQ 200MG BASE TABLET / ORAL AB 2007-11-14 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 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 · 14 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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
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 42043-120 Cefpodoxime Proxetil Cefpodoxime Proxetil OrchidPharma Inc ANDA Current 42043-121 Cefpodoxime Proxetil Cefpodoxime Proxetil OrchidPharma Inc ANDA Current