Home Applications 205332 Application 205332
Type ANDA
Sponsor AUROBINDO PHARMA LTD 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 A205332-001 IBANDRONATE SODIUM IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205332-001 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 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205332-001 IBANDRONATE SODIUM EQ 3MG BASE/3ML INJECTABLE / INTRAVENOUS AP 2015-08-19 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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 55150-191 Ibandronate Sodium Ibandronate Sodium AuroMedics Pharma LLC ANDA Current 55150-191 Ibandronate Sodium Ibandronate Sodium AuroMedics Pharma LLC ANDA Current 55150-191 Ibandronate Sodium Ibandronate Sodium AuroMedics Pharma LLC ANDA Current 55150-191 Ibandronate Sodium Ibandronate Sodium AuroMedics Pharma LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 32652 ORIG 2015-08-21