Home Applications 065152 Application 065152
Type ANDA
Sponsor YUNG SHIN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEPHALEXIN CEPHALEXIN CAPSULE;ORAL EQ 250MG BASE No No 002 CEPHALEXIN CEPHALEXIN CAPSULE;ORAL EQ 500MG 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 A065152-001 CEPHALEXIN CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 A065152-002 CEPHALEXIN CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24
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 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A065152-001 CEPHALEXIN EQ 250MG BASE CAPSULE / ORAL AB 2005-02-24 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A065152-002 CEPHALEXIN EQ 500MG BASE CAPSULE / ORAL AB 2005-02-24 bb7c543d1eb4…
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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10544-025 Cephalexin Cephalexin Blenheim Pharmacal, Inc. ANDA Current 24979-154 Cephalexin Cephalexin TWi Pharmaceuticals, Inc. ANDA Current 24979-155 Cephalexin Cephalexin TWi Pharmaceuticals, Inc. ANDA Current 61442-161 Cephalexin Cephalexin Carlsbad Technology, Inc. ANDA Current 61442-162 Cephalexin Cephalexin Carlsbad Technology, Inc. ANDA Current 61919-798 CEPHALEXIN ORAL SUSP CEPHALEXIN ORAL SUSP DIRECTRX ANDA Current 68071-5016 Cephalexin Cephalexin NuCare Pharmaceuticals,Inc. ANDA Current 68071-5016 Cephalexin Cephalexin NuCare Pharmaceuticals,Inc. ANDA Current 68788-7271 Cephalexin Cephalexin Preferred Pharmaceuticals Inc. ANDA Current 69778-930 Cephalexin Cephalexin Pharma-C, Inc. ANDA Current 69778-931 Cephalexin Cephalexin Pharma-C, Inc. ANDA Current