Application 204016
- Type
- NDA
- Sponsor
- HOSPIRA INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZOLEDRONIC ACID | ZOLEDRONIC ACID | SOLUTION;INTRAVENOUS | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N204016-001 | ZOLEDRONIC ACID | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N204016-001 | ZOLEDRONIC ACID | EQ 4MG BASE/100ML (EQ 0.04MG BASE/ML) | SOLUTION / INTRAVENOUS | 2015-12-28 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Zoledronic Acid | ZOLEDRONIC ACID | Dr. Reddy's Laboratories Limited | 1738a682-5903-b675-3a7a-61d299a6f248 | 2023-10-30 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic acid | ZOLEDRONIC ACID | Mylan Institutional LLC | 20cd29cc-cef5-48c4-adfe-6b3dfee0ab61 | 2023-10-18 | Warnings, Adverse reactions | Zoledronic acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Fresenius Kabi USA, LLC | 16fcf8c9-ef8a-4e93-9ee6-acfadd35a861 | 2023-09-21 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic acid | ZOLEDRONIC ACID | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 00a5bd5a-e5ee-4bad-b510-a4d4485485c8 | 2023-09-18 | Warnings, Adverse reactions | Zoledronic acid ZOLEDRONIC ACID |
| Zoledronic acid | ZOLEDRONIC ACID | NORTHSTAR RX LLC | 3885488c-6b83-421b-afee-61abceb95634 | 2023-09-06 | Warnings, Adverse reactions | Zoledronic acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Fresenius Kabi USA, LLC | f3f9de47-3d85-4d0c-a29e-1635cad3a970 | 2023-08-24 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic acid | ZOLEDRONIC ACID | BluePoint Laboratories | 666b1833-ee9b-4a6f-bd4c-9526552cec0a | 2023-07-27 | Warnings, Adverse reactions | Zoledronic acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Meitheal Pharmaceuticals Inc. | 8aac81ae-f92c-4f0b-b480-44badf72b5f5 | 2023-06-12 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Westminster Pharmaceuticals, LLC | 6a153c94-3cb5-4c05-98b2-1e18f5f3fe80 | 2023-02-02 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | AuroMedics Pharma LLC | ac7ff1eb-6e73-4cc8-9114-c5a4483ad4c3 | 2021-11-29 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| zoledronic acid | ZOLEDRONIC ACID | Sagent Pharmaceuticals | deb89be7-f40e-4fd4-a2cb-96634b45da84 | 2021-09-20 | Warnings, Adverse reactions | zoledronic acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Hikma Pharmaceuticals USA Inc. | 784d33fa-0046-42eb-894b-3fc47dcfd4dc | 2021-01-01 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Gland Pharma Limited | 1740d7d8-a101-4688-8d8b-beb00559d602 | 2019-04-02 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
| Zoledronic acid | ZOLEDRONIC ACID | Dr. Reddy's Laboratories Inc | b165df31-52f0-d67f-71e7-f3b4f18d2f15 | 2018-05-16 | Warnings, Adverse reactions | Zoledronic acid ZOLEDRONIC ACID |
| Zoledronic Acid | ZOLEDRONIC ACID | Dr.Reddy's Laboratories Inc | c8e02635-4473-8ba2-248f-ced58dbeabce | 2017-07-20 | Warnings, Adverse reactions | Zoledronic Acid ZOLEDRONIC ACID |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0409-4229 | Zoledronic Acid | ZOLEDRONIC ACID | Hospira, Inc. | NDA | Current |