Application 020988
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PROTONIX IV | PANTOPRAZOLE SODIUM | INJECTABLE;IV (INFUSION) | EQ 40MG BASE/VIAL | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020988-001 | PROTONIX IV | PANTOPRAZOLE SODIUM | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| N020988-001 | AP |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| N020988-001 | NPP | 2027-08-12 |
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 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / IV (INFUSION) | AP | RLD, RS | 2001-03-22 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020988-001 | PROTONIX IV | EQ 40MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | RLD, RS | 2001-03-22 | cb3db0bc1861… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020988-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020988-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020988-001 | AP | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020988-001 | AP | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020988-001 | AP | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020988-001 | AP | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020988-001 | AP | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020988-001 | AP | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020988-001 | AP | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020988-001 | AP | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020988-001 | AP | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020988-001 | AP | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020988-001 | AP | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | N020988-001 | AP | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020988-001 | AP | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | N020988-001 | AP | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | N020988-001 | AP | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | AP | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | N020988-001 | AP | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | AP | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | AP | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | AP | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N020988-001 | AP | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N020988-001 | AP | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N020988-001 | AP | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N020988-001 | AP | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N020988-001 | AP | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020988-001 | AP | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N020988-001 | AP | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N020988-001 | AP | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020988-001 | AP | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020988-001 | AP | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020988-001 | AP | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020988-001 | AP | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N020988-001 | AP | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N020988-001 | AP | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020988-001 | AP | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N020988-001 | AP | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N020988-001 | AP | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N020988-001 | AP | 1 | cb3db0bc1861… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | 6780881 | 2021-11-17 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | 7351723 | 2021-11-17 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | 8754108 | 2021-11-17 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | 6780881 | 2021-11-17 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | 7351723 | 2021-11-17 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | 8754108 | 2021-11-17 | Drug product | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | 6780881 | 2021-11-17 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | 7351723 | 2021-11-17 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | 8754108 | 2021-11-17 | Drug product | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | 6780881 | 2021-11-17 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | 7351723 | 2021-11-17 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | 8754108 | 2021-11-17 | Drug product | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | 7351723*PED | 2022-05-17 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N020988-001 | 8754108*PED | 2022-05-17 | Pediatric extension | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020988-001 | 6780881 | 2021-11-17 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020988-001 | 7351723 | 2021-11-17 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020988-001 | 8754108 | 2021-11-17 | Drug product | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N020988-001 | 6780881*PED | 2022-05-17 | Pediatric extension | 8869cabd3fbd… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N020988-001 | NPP | 2027-08-12 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020988-001 | NPP | 2027-08-12 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | N020988-001 | NPP | 2027-08-12 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020988-001 | NPP | 2027-08-12 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020988-001 | NPP | 2027-08-12 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020988-001 | NPP | 2027-08-12 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020988-001 | NPP | 2027-08-12 | 2680178bc6a6… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020988-001 | NPP | 2027-08-12 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | N020988-001 | NPP | 2027-08-12 | d06236e962d9… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N020988-001 | NPP | 2027-08-12 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Protonix I.V. | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | 51e4144a-489e-436c-609a-39305f8f56ba | 2025-12-22 | Warnings, Adverse reactions | 020988 NDA020988 0008-0923 |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | f39b3e7d-39d2-4c8a-9974-4ab885241880 | 2025-12-22 | Warnings, Adverse reactions | 020988 NDA020988 0008-4001 |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 50802e19-72d3-4130-8d14-eb94361b38e7 | 2025-08-19 | Warnings, Adverse reactions | 020988 NDA020988 55154-4236 |
| Protonix I.V. | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | 3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b | 2025-04-22 | Warnings, Adverse reactions | 020988 NDA020988 55154-4225 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0923 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0941 | Protonix | pantoprazole sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0941 | Protonix | pantoprazole sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-0941 | Protonix | pantoprazole sodium | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC | NDA | Current |
| 0008-2001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0008-4001 | Protonix | PANTOPRAZOLE SODIUM | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 55154-4225 | Protonix | pantoprazole sodium | Cardinal Health | NDA | Current |
| 55154-4225 | Protonix | pantoprazole sodium | Cardinal Health | NDA | Current |
| 55154-4225 | Protonix | pantoprazole sodium | Cardinal Health 107, LLC | NDA | Current |
| 55154-4234 | Protonix | pantoprazole sodium | Cardinal Health | NDA | Current |
| 55154-4236 | Protonix | PANTOPRAZOLE SODIUM | Cardinal Health | NDA | Current |
| 55154-4236 | Protonix | PANTOPRAZOLE SODIUM | Cardinal Health | NDA | Current |
| 55154-4236 | Protonix | PANTOPRAZOLE SODIUM | Cardinal Health 107, LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 79383 | SUPPL | 2024-08-13 |
| 79381 | SUPPL | 2024-08-13 |
| 74815 | SUPPL | 2023-07-20 |
| 74778 | SUPPL | 2023-07-19 |
| 70467 | SUPPL | 2022-03-10 |
| 70423 | SUPPL | 2022-03-07 |
| 65423 | SUPPL | 2020-12-01 |
| 65368 | SUPPL | 2020-11-30 |
| 60234 | SUPPL | 2019-10-04 |
| 60226 | SUPPL | 2019-10-04 |
| 58449 | SUPPL | 2019-04-26 |
| 58437 | SUPPL | 2019-04-26 |
| 54569 | SUPPL | 2018-06-14 |
| 54506 | SUPPL | 2018-06-11 |
| 50877 | SUPPL | 2017-12-27 |
| 50840 | SUPPL | 2017-12-22 |
| 48938 | SUPPL | 2017-07-10 |
| 48930 | SUPPL | 2017-07-07 |
| 45719 | SUPPL | 2016-10-31 |
| 45654 | SUPPL | 2016-10-26 |
| 35825 | SUPPL | 2014-12-29 |
| 26410 | SUPPL | 2014-12-23 |
| 35824 | SUPPL | 2013-12-17 |
| 3980 | SUPPL | 2013-12-16 |
| 26408 | SUPPL | 2012-10-02 |
| 35823 | SUPPL | 2012-10-01 |
| 14109 | SUPPL | 2012-05-16 |
| 26409 | SUPPL | 2012-05-14 |
| 23615 | ORIG | 2011-12-20 |
| 35821 | SUPPL | 2011-12-14 |
| 26406 | SUPPL | 2011-12-13 |
| 14108 | SUPPL | 2011-06-27 |
| 26405 | SUPPL | 2011-06-09 |
| 35822 | SUPPL | 2011-05-25 |
| 26407 | SUPPL | 2011-05-25 |
| 35820 | SUPPL | 2010-09-10 |
| 3979 | SUPPL | 2010-09-08 |
| 3978 | SUPPL | 2008-01-09 |
| 35819 | SUPPL | 2005-08-08 |
| 14107 | SUPPL | 2005-08-08 |
| 3977 | SUPPL | 2005-08-08 |
| 3976 | SUPPL | 2005-08-08 |
| 14106 | SUPPL | 2004-12-08 |
| 3974 | SUPPL | 2004-12-08 |
| 3975 | SUPPL | 2004-12-02 |
| 26404 | SUPPL | 2004-10-29 |
| 26401 | SUPPL | 2004-05-07 |
| 14104 | SUPPL | 2004-05-07 |
| 26403 | SUPPL | 2004-04-07 |
| 26402 | SUPPL | 2004-04-07 |
| 35818 | SUPPL | 2004-04-05 |
| 35815 | SUPPL | 2004-04-05 |
| 14105 | SUPPL | 2004-04-05 |
| 26399 | SUPPL | 2004-03-10 |
| 35817 | SUPPL | 2004-01-15 |
| 3973 | SUPPL | 2004-01-14 |
| 3972 | SUPPL | 2004-01-14 |
| 35816 | SUPPL | 2003-12-01 |
| 3971 | SUPPL | 2003-11-26 |
| 26400 | SUPPL | 2003-11-05 |
| 26398 | SUPPL | 2003-03-10 |
| 3970 | SUPPL | 2002-10-28 |
| 35814 | SUPPL | 2001-10-19 |
| 3969 | SUPPL | 2001-10-19 |
| 41863 | ORIG | 2001-03-22 |
| 35813 | ORIG | 2001-03-22 |
| 26397 | ORIG | 2001-03-22 |