Home Applications 065396 Application 065396
Type ANDA
Sponsor LUPIN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION;ORAL EQ 250MG BASE/5ML No No 002 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE FOR SUSPENSION;ORAL EQ 500MG BASE/5ML No Yes
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 A065396-001 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 A065396-002 CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21
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 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A065396-001 CEFADROXIL EQ 250MG BASE/5ML FOR SUSPENSION / ORAL AB 2008-02-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A065396-002 CEFADROXIL EQ 500MG BASE/5ML FOR SUSPENSION / ORAL AB RS 2008-02-21 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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68180-181 Cefadroxil Cefadroxil Lupin Pharmaceuticals, Inc. ANDA Current 68180-181 Cefadroxil Cefadroxil Lupin Pharmaceuticals, Inc. ANDA Current 68180-182 Cefadroxil Cefadroxil Lupin Pharmaceuticals, Inc. ANDA Current 68180-182 Cefadroxil Cefadroxil Lupin Pharmaceuticals, Inc. ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 39423 SUPPL 2014-04-22 8397 ORIG 2010-11-10 39422 ORIG 2010-10-26