Home Applications 204222 Application 204222
Type ANDA
Sponsor APOTEX Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IBANDRONATE SODIUM IBANDRONATE SODIUM INJECTABLE;INTRAVENOUS EQ 3MG BASE/3ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A204222-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A204222-001 AP
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 · 42 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 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-10-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A204222-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP RS 2015-10-16 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 60505-6097 Ibandronate Sodium ibandronate sodium Apotex Corp. ANDA Current 60505-6097 Ibandronate Sodium ibandronate sodium Apotex Corp. ANDA Current