Home Applications 065276 Application 065276
Type ANDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFPROZIL CEFPROZIL TABLET;ORAL 250MG No No 002 CEFPROZIL CEFPROZIL TABLET;ORAL 500MG 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 A065276-001 CEFPROZIL CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 A065276-002 CEFPROZIL CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08
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 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065276-001 CEFPROZIL 250MG TABLET / ORAL AB 2005-12-08 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065276-002 CEFPROZIL 500MG TABLET / ORAL AB RS 2005-12-08 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 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43063-842 CEFPROZIL CEFPROZIL PD-Rx Pharmaceuticals, Inc. ANDA Current 52959-300 CEFPROZIL CEFPROZIL H. J. Harkins Company, Inc. ANDA Current 53217-031 CEFPROZIL CEFPROZIL Aidarex Pharmaceuticals LLC ANDA Current 57297-403 CEFPROZIL CEFPROZIL LUPIN LIMITED ANDA Current 57297-404 CEFPROZIL CEFPROZIL LUPIN LIMITED ANDA Current 67296-0590 CEFPROZIL CEFPROZIL RedPharm Drug Inc. ANDA Current 68180-403 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-403 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-403 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-403 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-404 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-404 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-404 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current 68180-404 CEFPROZIL CEFPROZIL Lupin Pharmaceuticals, Inc. ANDA Current