Application 077058
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 20MG BASE | No | No |
| 002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | TABLET, DELAYED RELEASE;ORAL | EQ 40MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077058-001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | ||
| A077058-002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 |
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 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077058-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077058-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-09-10 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|
| 42254-124 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Rebel Distributors Corp | ANDA | Current |
| 50436-8101 | PANTOPRAZOLE SODIUM | Pantoprazole Sodium | Unit Dose Services | ANDA | Current |
| 53808-1047 | Pantoprazole Sodium | Pantoprazole Sodium | State of Florida DOH Central Pharmacy | ANDA | Current |
| 58517-420 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | New Horizon Rx Group, LLC | ANDA | Current |
| 61919-866 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | DirectRX | ANDA | Current |