Application 091231
- Type
- ANDA
- Sponsor
- WOCKHARDT
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 |
|---|---|---|---|---|---|---|---|
| A091231-001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | |
| A091231-002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091231-001 | AB |
| A091231-002 | AB |
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 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091231-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A091231-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2011-01-19 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A091231-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091231-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091231-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091231-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091231-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091231-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091231-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091231-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091231-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091231-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091231-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091231-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091231-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091231-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091231-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091231-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091231-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091231-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091231-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091231-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091231-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091231-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091231-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091231-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091231-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091231-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091231-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A091231-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091231-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091231-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091231-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A091231-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091231-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A091231-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091231-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A091231-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091231-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A091231-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091231-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A091231-002 | AB | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50436-8102 | PANTOPRAZOLE SODIUM | Pantoprazole sodium | Unit Dose Services | ANDA | Current |
| 55648-433 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 55648-434 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | WOCKHARDT LIMITED | ANDA | Current |
| 64679-433 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-433 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-433 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-434 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-434 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 64679-434 | Pantoprazole sodium | Pantoprazole sodium | Wockhardt USA LLC. | ANDA | Current |
| 68788-9557 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Preferred Pharmaceuticals, Inc. | ANDA | Current |