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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077056-001 | PANTOPRAZOLE SODIUM | EQ 20MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077056-002 | PANTOPRAZOLE SODIUM | EQ 40MG BASE | TABLET, DELAYED RELEASE / ORAL | 2007-08-02 | caaa826d4ba7… | ||
| 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… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Devatis Inc. | 13c337e7-1e7b-47bd-9f88-92b0d548ca9c | 2025-07-30 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Mylan Institutional Inc. | a9b0d279-118b-4372-bd51-d4bad9c1cfca | 2025-07-22 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Meitheal Pharmaceuticals Inc. | 014f9762-6948-46b7-8659-5c89f35ad8bf | 2025-06-27 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Aphena Pharma Solutions - Tennessee, LLC | c9bc288b-e84c-4e31-a769-c87a59226086 | 2025-06-09 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b | 2025-04-22 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM INJECTION | Alembic Pharmaceuticals Limited | 02ee7ed6-217f-4128-bbbb-b9390475a65b | 2025-04-07 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM INJECTION | Alembic Pharmaceuticals Inc. | a9e5fac6-2db6-4311-a98b-eb3f0dde19d6 | 2025-04-07 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Rising Pharma Holdings, Inc. | 91a6b13f-457f-4136-9541-c4adb9c3c35c | 2025-04-02 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Aurobindo Pharma Limited | b3cec41e-e98b-470a-8ba2-c31537023989 | 2025-04-02 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM |
| Pantoprazole sodium | PANTOPRAZOLE SODIUM | Sun Pharmaceutical Industries Limited | eb3f58d4-0c69-4377-be45-c36099c98d33 | 2025-04-01 | Warnings, Adverse reactions | Pantoprazole sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | A-S Medication Solutions | 81696241-17d5-4d35-9e59-8c28469ffd2c | 2025-03-14 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | Meitheal Pharmaceuticals Inc. | c18aff31-f91e-4b6a-9713-52c9094c6082 | 2025-03-13 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| Pantoprazole sodium | PANTOPRAZOLE SODIUM | BE Pharmaceuticals Inc. | 52d5bc28-66df-43aa-bb1a-8ac4a2a7f693 | 2025-03-07 | Warnings, Adverse reactions | Pantoprazole sodium PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium | PANTOPRAZOLE SODIUM | NuCare Pharmaceuticals,Inc. | 8aac1642-6cb0-6ad2-e053-2a95a90a4cbd | 2025-01-31 | Warnings, Adverse reactions | Pantoprazole Sodium PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE SODIUM | Sun Pharmaceutical Industries, Inc. | d9fcf6a2-3788-4955-84d9-3c319b13267c | 2025-01-22 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM PANTOPRAZOLE SODIUM |
| PANTOPRAZOLE SODIUM | PANTOPRAZOLE | DIRECT RX | a7e7c1ab-3e75-1ff8-e053-2995a90a7539 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium DR | PANTOPRAZOLE SODIUM | Advanced Rx of Tennessee, LLC | b3277cb8-26d0-bce0-e053-2a95a90af6dd | 2024-12-31 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium DR | PANTOPRAZOLE SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | c89a5396-1d94-c7fa-e053-2995a90a9063 | 2024-12-31 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium DR | PANTOPRAZOLE SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | bd4759ac-46b5-6903-e053-2a95a90a6319 | 2024-12-31 | Warnings, Adverse reactions | PANTOPRAZOLE SODIUM |
| Pantoprazole Sodium DR | PANTOPRAZOLE SODIUM | Advanced Rx Pharmacy of Tennessee, LLC | d27e1fdd-e23f-0d60-e053-2a95a90a9087 | 2024-12-31 | Warnings, Adverse reactions | 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 |
|---|---|---|---|---|---|
| 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 |