Application 077056
- Type
- ANDA
- Sponsor
- TEVA
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 |
|---|---|---|---|---|---|---|---|
| A077056-001 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | ||
| A077056-002 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 |
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 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2007-08-02 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | AB | 2007-08-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077056-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077056-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077056-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077056-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077056-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077056-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077056-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077056-002 | AB | 1 | ea99ee380514… |
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 |
|---|---|---|---|---|---|
| 0093-0011 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0011 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0011 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0012 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0012 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0012 | Pantoprazole Sodium | Pantoprazole Sodium | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-7916 | Pantoprazole Sodium | Pantoprazole Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7998 | Pantoprazole Sodium | Pantoprazole Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7998 | Pantoprazole Sodium | Pantoprazole Sodium | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 21695-771 | Pantoprazole Sodium | Pantoprazole Sodium | Rebel Distributors Corp | ANDA | Current |
| 33358-536 | Pantoprazole Sodium | Pantoprazole Sodium | RxChange Co. | ANDA | Current |
| 42291-658 | Pantoprazole Sodium | Pantoprazole Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-658 | Pantoprazole Sodium | Pantoprazole Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-659 | Pantoprazole Sodium | Pantoprazole Sodium | AvKARE, Inc. | ANDA | Current |
| 42291-659 | Pantoprazole Sodium | Pantoprazole Sodium | AvKARE, Inc. | ANDA | Current |
| 42708-069 | Pantoprazole Sodium | Pantoprazole Sodium | QPharma Inc | ANDA | Current |
| 42708-069 | Pantoprazole Sodium | Pantoprazole Sodium | QPharma Inc | ANDA | Current |
| 43353-343 | Pantoprazole Sodium | Pantoprazole Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-622 | Pantoprazole Sodium | Pantoprazole Sodium | Medsource Pharmaceuticals | ANDA | Current |
| 45865-622 | Pantoprazole Sodium | Pantoprazole Sodium | Medsource Pharmaceuticals | ANDA | Current |
| 50090-1415 | Pantoprazole Sodium | Pantoprazole Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-1415 | Pantoprazole Sodium | Pantoprazole Sodium | A-S Medication Solutions | ANDA | Current |
| 50090-3095 | Pantoprazole Sodium | Pantoprazole Sodium | A-S Medication Solutions | ANDA | Current |
| 51655-501 | Pantoprazole Sodium | Pantoprazole Sodium | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 55700-314 | Pantoprazole Sodium | Pantoprazole Sodium | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-134 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 61919-134 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 61919-134 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 61919-599 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 61919-599 | PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | DIRECT RX | ANDA | Current |
| 63187-119 | Pantoprazole Sodium | Pantoprazole Sodium | Proficient Rx LP | ANDA | Current |
| 63187-551 | Pantoprazole Sodium | Pantoprazole Sodium | Proficient Rx LP | ANDA | Current |
| 63629-3353 | Pantoprazole Sodium | Pantoprazole Sodium | Bryant Ranch Prepack | ANDA | Current |
| 63629-6533 | Pantoprazole Sodium | Pantoprazole Sodium | Bryant Ranch Prepack | ANDA | Current |
| 67046-534 | Pantoprazole Sodium | Pantoprazole Sodium | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-2082 | Pantoprazole Sodium | Pantoprazole Sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-2195 | Pantoprazole Sodium | Pantoprazole Sodium | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-4347 | Pantoprazole Sodium | Pantoprazole Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4483 | Pantoprazole Sodium | Pantoprazole Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4483 | Pantoprazole Sodium | Pantoprazole Sodium | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-9254 | Pantoprazole Sodium | Pantoprazole Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9263 | Pantoprazole Sodium | Pantoprazole Sodium | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0395 | Pantoprazole Sodium | Pantoprazole Sodium | REMEDYREPACK INC. | ANDA | Current |
| 71610-103 | Pantoprazole Sodium | Pantoprazole Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-341 | Pantoprazole Sodium | Pantoprazole Sodium | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 8998 | ORIG | 2006-04-25 |