Application 204329
- Type
- ANDA
- Sponsor
- NANG KUANG PHARM CO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204329-001 | IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 |
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.
| 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 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 4b0b4de00fa7… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | AP | 2021-06-16 | 782e0a99824c… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A204329-001 | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE / INTRAVENOUS | 2021-06-16 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2021-12-28 21:50 UTC | 2021-12 | A204329-001 | AP | 1 | 782e0a99824c… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Ibandronate Sodium | IBANDRONATE SODIUM | Aurobindo Pharma Limited | 86c0b4ae-5e38-4efe-88af-50ac560e294f | 2026-03-18 | Warnings, Adverse reactions | Ibandronate Sodium IBANDRONATE SODIUM |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | Sun Pharmaceutical Industries, Inc. | be514be6-727a-4d6c-993b-52144f8e6de8 | 2026-03-03 | Warnings, Adverse reactions | IBANDRONATE SODIUM IBANDRONATE SODIUM |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | Golden State Medical Supply, Inc. | 618e1aff-ccbb-4cee-93f1-fe04e33dacb7 | 2026-02-19 | Warnings, Adverse reactions | IBANDRONATE SODIUM IBANDRONATE SODIUM |
| Ibandronate sodium | IBANDRONATE SODIUM | Dr. Reddy's Laboratories Limited | f94d9c49-245a-8081-42c4-785113fce498 | 2026-02-16 | Warnings, Adverse reactions | Ibandronate sodium IBANDRONATE SODIUM |
| Ibandronate Sodium | IBANDRONATE SODIUM | Eugia US LLC | e81f2c5b-bead-48ac-be3e-016cf963d7ed | 2026-01-27 | Warnings, Adverse reactions | Ibandronate Sodium IBANDRONATE SODIUM |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | Macleods Pharmaceuticals Limited | a5741ef6-0599-4657-8cda-2902ded4f680 | 2026-01-19 | Warnings, Adverse reactions | IBANDRONATE SODIUM IBANDRONATE SODIUM |
| Ibandronate Sodium | IBANDRONATE SODIUM | Apotex Corp. | 9fad4982-95af-d711-f50a-867311835143 | 2026-01-15 | Warnings, Adverse reactions | Ibandronate Sodium IBANDRONATE SODIUM |
| Ibandronate sodium | IBANDRONATE SODIUM | A-S Medication Solutions | e5b6c2a9-a55f-41f9-a592-e26ef03e2d73 | 2025-09-22 | Warnings, Adverse reactions | Ibandronate sodium IBANDRONATE SODIUM |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | Bionpharma Inc. | 6ca94cce-a2bb-421f-bd8f-6b14bc2bd985 | 2023-05-23 | Warnings, Adverse reactions | IBANDRONATE SODIUM IBANDRONATE SODIUM |