Home Applications 216845 Application 216845
Type ANDA
Sponsor AUROBINDO PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 500MG BASE No No 002 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 500MG 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 A216845-001 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 A216845-002 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23
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 2 · 52 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 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216845-001 DICLOXACILLIN SODIUM EQ 250MG BASE CAPSULE / ORAL AB 2022-09-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216845-002 DICLOXACILLIN SODIUM EQ 500MG BASE CAPSULE / ORAL AB 2022-09-23 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 52 observed states.
Observed Orange Book exclusivity history# 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59651-565 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM Aurobindo Pharma Limited ANDA Current 59651-566 DICLOXACILLIN SODIUM DICLOXACILLIN SODIUM Aurobindo Pharma Limited ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 72742 ORIG 2022-11-28