Application 080751
- Type
- ANDA
- Sponsor
- NOVARTIS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | INFLAMASE MILD | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.11% PHOSPHATE | No | No |
| 002 | INFLAMASE FORTE | PREDNISOLONE SODIUM PHOSPHATE | SOLUTION/DROPS;OPHTHALMIC | EQ 0.9% PHOSPHATE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080751-001 | INFLAMASE MILD | PREDNISOLONE SODIUM PHOSPHATE | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | ||
| A080751-002 | INFLAMASE FORTE | PREDNISOLONE SODIUM PHOSPHATE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 |
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 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080751-001 | INFLAMASE MILD | EQ 0.11% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080751-002 | INFLAMASE FORTE | EQ 0.9% PHOSPHATE | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | ATLANTIC BIOLOGICALS CORP. | 96de9cad-2fb7-4947-87ae-4db57563a83a | 2026-09-04 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Preferred Pharmaceuticals, Inc. | 93b372f7-b811-4c15-85c4-c6dbac342cb4 | 2026-08-18 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| PrednisoLONE Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | PAI Holdings, LLC dba PAI Pharma | d1f937e7-fed5-4079-bd52-5d930b34ae9f | 2026-06-25 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| prednisoLONE sodium phosphate | PREDNISOLONE SODIUM PHOSPHATE | Kesin Pharma | 4c0dcbfd-2848-9bd0-e063-6394a90af5a7 | 2026-03-27 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Chartwell RX, LLC. | 2d8c861d-3756-4b75-aaa9-1b82cf11eb94 | 2026-02-13 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | REMEDYREPACK INC. | f87ce1ba-335e-463d-87d5-9af0206f8f61 | 2026-02-10 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Redpharm Drug | 3253b63b-0533-6cdc-e063-6294a90aa311 | 2025-12-24 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Edenbridge Pharmaceuticals LLC. | 1793e218-7b49-497d-879f-1020de6e6d68 | 2025-12-17 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Chartwell Governmental & Specialty RX, LLC. | 5ec401b5-132a-4cd2-8c24-6a5c8b63c2f9 | 2025-12-05 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate Oral Solution | PREDNISOLONE SODIUM PHOSPHATE | BioComp Pharma, Inc. | 95208441-1700-5d3f-e053-2a95a90a7da2 | 2025-12-03 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Preferred Pharmaceuticals Inc. | 7262fc84-3db2-4475-8ae4-6bec4477cb81 | 2025-10-28 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Atlantic Biologicals Corp | 401f7ba6-a4a2-9ae6-e063-6394a90a4210 | 2025-10-01 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | PAI Holdings, LLC dba PAI Pharma | a0d74ae0-7b2d-4d36-9211-c76f5063b5a9 | 2025-07-10 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Orapred ODT | PREDNISOLONE SODIUM PHOSPHATE | Advanz Pharma (US) Corp. | 1e379543-c4cf-4e72-953b-db15b7f0c2a1 | 2025-06-03 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Amneal Pharmaceuticals NY LLC | 286a6032-41de-435a-b6e6-14052b66b85d | 2025-04-29 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | A-S Medication Solutions | 4c507319-8add-4952-8bea-ff77ab17088f | 2025-02-28 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | PAI Holdings, LLC dba PAI Pharma | acc8badf-d9fd-4f99-a650-a149138b68b1 | 2025-02-11 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | PAI Holdings, LLC dba PAI Pharma | 93cd0ddd-1cf5-4064-9a4c-015819c0065a | 2025-02-10 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| Prednisolone Sodium Phosphate | PREDNISOLONE SODIUM PHOSPHATE | Seton Pharmaceuticals, LLC | 833ba492-8823-43b4-9a91-8b28d94a740b | 2024-09-23 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
| prednisolone sodium phosphate ODT | PREDNISOLONE SODIUM PHOSPHATE | Ingenus Pharmaceuticals, LLC | ebbc1751-9381-4db1-89ff-ae5a2963fb2c | 2024-04-18 | Warnings, Adverse reactions | PREDNISOLONE SODIUM PHOSPHATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.