Application 021959
- Type
- NDA
- Sponsor
- CONCORDIA PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 10MG BASE | Yes | No |
| 002 | ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 15MG BASE | Yes | No |
| 003 | ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | TABLET, ORALLY DISINTEGRATING;ORAL | EQ 30MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021959-001 | ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | |
| N021959-002 | ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | |
| N021959-003 | ORAPRED ODT | PREDNISOLONE SODIUM PHOSPHATE | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 |
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 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021959-002 | ORAPRED ODT | EQ 15MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021959-003 | ORAPRED ODT | EQ 30MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2006-06-01 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021959-001 | ORAPRED ODT | EQ 10MG BASE | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2006-06-01 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021959-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021959-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N021959-003 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021959-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021959-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021959-003 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N021959-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021959-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N021959-003 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N021959-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021959-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N021959-003 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N021959-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021959-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N021959-003 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N021959-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021959-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N021959-003 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N021959-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021959-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N021959-003 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N021959-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021959-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N021959-003 | AB | 1 | ea99ee380514… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N021959-001 | 6740341 | 2019-11-24 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021959-002 | 6740341 | 2019-11-24 | Drug product | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N021959-003 | 6740341 | 2019-11-24 | Drug product | 74a2ff9319b5… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021959-001 | 6740341 | 2019-11-24 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021959-002 | 6740341 | 2019-11-24 | Drug product | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N021959-003 | 6740341 | 2019-11-24 | Drug product | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021959-001 | 6740341 | 2019-11-24 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021959-002 | 6740341 | 2019-11-24 | Drug product | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N021959-003 | 6740341 | 2019-11-24 | Drug product | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021959-001 | 6740341 | 2019-11-24 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021959-002 | 6740341 | 2019-11-24 | Drug product | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N021959-003 | 6740341 | 2019-11-24 | Drug product | 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 |
|---|---|---|---|---|---|---|
| Orapred ODT | PREDNISOLONE SODIUM PHOSPHATE | Advanz Pharma (US) Corp. | 1e379543-c4cf-4e72-953b-db15b7f0c2a1 | 2025-06-03 | Warnings, Adverse reactions | 021959 NDA021959 59212-700 59212-701 59212-702 |
| prednisolone sodium phosphate ODT | PREDNISOLONE SODIUM PHOSPHATE | Ingenus Pharmaceuticals, LLC | ebbc1751-9381-4db1-89ff-ae5a2963fb2c | 2024-04-18 | Warnings, Adverse reactions | 021959 NDA021959 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59212-700 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-700 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-700 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-700 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-700 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-701 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-701 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-701 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-701 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-701 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-702 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-702 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-702 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-702 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 59212-702 | Orapred | prednisolone sodium phosphate | Concordia Pharmaceuticals Inc. | NDA | Current |
| 66993-844 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-844 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-844 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-844 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-844 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-844 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-845 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-845 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-845 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-845 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-845 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-845 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-846 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-846 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-846 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-846 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-846 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |
| 66993-846 | Prednisolone Sodium Phosphate | prednisolone sodium phosphate | Prasco Laboratories | NDA AUTHORIZED GENERIC | Current |