Application 090296
- Type
- ANDA
- Sponsor
- SANDOZ INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | INJECTABLE;IV (INFUSION) | EQ 40MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090296-001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | 2015-07-14 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | 2015-07-14 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090296-001 | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2015-07-14 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090296-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090296-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090296-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090296-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090296-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090296-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090296-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090296-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090296-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090296-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090296-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090296-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090296-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090296-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090296-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090296-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090296-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090296-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090296-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090296-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090296-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090296-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090296-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090296-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090296-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090296-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090296-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090296-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090296-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090296-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090296-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090296-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090296-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090296-001 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | A-S Medication Solutions | 3a8fa326-ad75-4b6d-8832-0a2357eeca2f | 2024-04-25 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Bryant Ranch Prepack | 3e5421ef-0875-4a04-b17d-95cca0052c83 | 2024-04-04 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Bryant Ranch Prepack | 617bb464-5357-472f-8e9d-61aae5b2ebef | 2024-04-03 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Golden State Medical Supply, Inc. | d6aae78e-308b-7072-e053-2a95a90aaa10 | 2024-03-29 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Asclemed USA, Inc. | 3540d01c-da0e-477e-9e90-994b96deb1d6 | 2024-03-13 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Asclemed USA, Inc. | ff15c4f1-8869-4422-9631-dc488e09e583 | 2024-02-14 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE | Baxter Healthcare Company | a476e063-9450-4793-9a22-16b0a0a61cd0 | 2024-02-14 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | A-S Medication Solutions | 517d6b02-0e68-4d6b-98b3-eac0be457e6b | 2023-12-16 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Camber Pharmaceuticals, Inc. | ee6278c0-d8c0-417c-a65c-b522ff76fe44 | 2023-11-02 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Mylan Pharmaceuticals Inc. | 56ad5b97-8e5f-48a5-b2ba-a5484b43d018 | 2023-08-15 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Sagent Pharmaceuticals | c39be14b-e881-4586-b77e-4747db494954 | 2023-08-14 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Sun Pharmaceutical Industries, Inc. | 38353b9e-63bd-47e8-b7cb-b198d1e901f9 | 2023-08-03 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | A-S Medication Solutions | f1eb666a-120d-47fd-8c9f-73cef839294a | 2023-07-31 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Lannett Company, Inc. | e7705bf6-e473-4b9c-bb5d-57e26ffe7b97 | 2023-07-21 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Hikma Pharmaceuticals USA Inc. | 1e102c44-232b-4aaf-b457-2a740c47193a | 2023-07-19 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Hikma Pharmaceuticals USA Inc. | b02f3f85-8f9b-4d06-8eae-73e592626f3e | 2023-07-10 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | c10e9c12-e39d-4b0b-bd4c-10d3e9a4cf34 | 2023-02-17 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | XLCare Pharmaceuticals Inc. | 17468dbf-84b6-4c53-9ad5-341350d2cfab | 2023-01-17 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | Aphena Pharma Solutions - Tennessee, LLC | e3f711d8-b9d3-46a6-8bf9-6af1cc77003e | 2022-07-15 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Proficient Rx LP | a03aa46f-9eb5-4cf4-addf-745d94af8261 | 2022-06-01 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0480-4111 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0781-3232 | Pantoprazole Sodium | Pantoprazole Sodium | Sandoz Inc | ANDA | Current |
| 0781-3232 | Pantoprazole Sodium | Pantoprazole Sodium | Sandoz Inc | ANDA | Current |
| 0781-3232 | Pantoprazole Sodium | Pantoprazole Sodium | Sandoz Inc | ANDA | Current |
| 0781-3232 | Pantoprazole Sodium | Pantoprazole Sodium | Sandoz Inc | ANDA | Current |
| 65219-433 | Pantoprazole Sodium | Pantoprazole Sodium | Fresenius Kabi USA, LLC | ANDA | Current |
| 72572-550 | Pantoprazole Sodium | Pantoprazole Sodium | Civica, Inc. | ANDA | Current |
| 72572-550 | Pantoprazole Sodium | Pantoprazole Sodium | Civica, Inc. | ANDA | Current |
| 72572-550 | Pantoprazole Sodium | Pantoprazole Sodium | Civica, Inc. | ANDA | Current |