Application 083021
- Type
- ANDA
- Sponsor
- AKORN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM SULFACETAMIDE | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 10% | No | No |
| 002 | SODIUM SULFACETAMIDE | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 15% | No | No |
| 003 | SODIUM SULFACETAMIDE | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 30% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A083021-001 | SODIUM SULFACETAMIDE | SULFACETAMIDE SODIUM | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ||
| A083021-002 | SODIUM SULFACETAMIDE | SULFACETAMIDE SODIUM | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ||
| A083021-003 | SODIUM SULFACETAMIDE | SULFACETAMIDE SODIUM | 30% | SOLUTION/DROPS / OPHTHALMIC | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083021-001 | SODIUM SULFACETAMIDE | 10% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083021-002 | SODIUM SULFACETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A083021-003 | SODIUM SULFACETAMIDE | 30% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Preferred Pharmaceuticals, Inc | cf0cc763-49b5-435d-852b-e7617c8d3286 | 2026-09-02 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| SODIUM SULFACETAMIDE | SODIUM SULFACETAMIDE | Acella Pharmaceuticals, LLC | 77671f48-b574-490f-a1c2-b321af8dac52 | 2026-07-13 | Warnings, Adverse reactions | SODIUM SULFACETAMIDE |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Bryant Ranch Prepack | 3cc796f7-b1e9-4804-9009-2bf578ba7a53 | 2026-04-24 | Warnings | Sodium Sulfacetamide |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Bryant Ranch Prepack | c9f90612-32c6-44ba-85d5-82842f0e1ba9 | 2026-04-24 | Warnings | Sodium Sulfacetamide |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Bryant Ranch Prepack | ed2ab442-617b-472a-a7a3-f178b5b8c441 | 2026-04-24 | Warnings | Sodium Sulfacetamide |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | A-S Medication Solutions | f212af23-be3d-4e82-9f6f-5ddce12a89da | 2026-03-23 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Method Pharmaceuticals, LLC | d65e777b-682b-732d-e053-2a95a90a41ad | 2026-02-12 | Warnings | Sodium Sulfacetamide |
| SODIUM SULFACETAMIDE | SODIUM SULFACETAMIDE | BioComp Pharma, Inc. | efde52a6-216d-4ccc-8574-5e3e41ec7e06 | 2026-01-12 | Warnings, Adverse reactions | SODIUM SULFACETAMIDE |
| OVACE | SULFACETAMIDE SODIUM | Mission Pharmacal Company | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 2026-01-08 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| SODIUM SULFACETAMIDE | SODIUM SULFACETAMIDE | BioComp Pharma, Inc. | d8954bfa-2acf-445a-9810-62cfd5d469b3 | 2025-12-17 | Warnings, Adverse reactions | SODIUM SULFACETAMIDE |
| Sodium Sulfacetamide, Sulfur | SULFACETAMIDE SODIUM | BioComp Pharma, Inc. | ed616ece-09b5-41d5-ae58-8e016da2c6b3 | 2025-12-17 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | BioComp Pharma, Inc. | f79c8287-a832-4f39-ad4d-3a12d64618ab | 2025-12-17 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | BioComp Pharma, Inc. | ac7863c6-387c-4c90-bfaa-5f1544e1e887 | 2025-12-17 | Warnings, Adverse reactions | Sodium Sulfacetamide |
| OVACE Plus | SULFACETAMIDE SODIUM | Mission Pharmacal Company | eca5fc5d-35d0-4803-990d-1f38f860c52a | 2025-12-03 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| OVACE Plus | SULFACETAMIDE SODIUM | Mission Pharmacal Company | 6a034465-e600-49cb-91bd-7b9ceee6ffc6 | 2025-12-03 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Ovace Plus | SULFACETAMIDE SODIUM | Mission Pharmacal Company | 073a44cd-f679-48bd-b90d-cf06f32ff07d | 2025-08-13 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| OvacePlus Plus | SULFACETAMIDE SODIUM | Mission Pharmacal Company | 06876575-edf2-4844-8f20-3eb6e74ccc8e | 2025-08-12 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Laser Pharmaceuticals, LLC | 055a586a-a840-0205-e063-6394a90a44cb | 2025-07-03 | Warnings, Adverse reactions | Sodium Sulfacetamide |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Laser Pharmaceuticals, LLC | bdc2211e-6d20-1500-e053-2a95a90ab145 | 2025-04-23 | Warnings, Adverse reactions | Sodium Sulfacetamide |
| Sodium Sulfacetamide | SODIUM SULFACETAMIDE | Bryant Ranch Prepack | acd3fb4a-558d-4565-84d8-23a0d917eab6 | 2024-12-24 | Warnings | Sodium Sulfacetamide |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.