Application 005963
- Type
- NDA
- Sponsor
- SCHERING
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SODIUM SULAMYD | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | SODIUM SULAMYD | SULFACETAMIDE SODIUM | OINTMENT;OPHTHALMIC | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | SODIUM SULAMYD | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N005963-001 | SODIUM SULAMYD | SULFACETAMIDE SODIUM | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | ||
| N005963-002 | SODIUM SULAMYD | SULFACETAMIDE SODIUM | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | ||
| N005963-003 | SODIUM SULAMYD | SULFACETAMIDE SODIUM | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 |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| 2026-08 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005963-002 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | OINTMENT / OPHTHALMIC | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N005963-003 | SODIUM SULAMYD | 30% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N005963-001 | SODIUM SULAMYD | 10% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION/DROPS / OPHTHALMIC | RLD, Approved before 1982 | 301d65b070ca… |
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 |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | A-S Medication Solutions | f212af23-be3d-4e82-9f6f-5ddce12a89da | 2026-03-23 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| OVACE | SULFACETAMIDE SODIUM | Mission Pharmacal Company | a77aed6c-355f-44ed-ae95-78b4d1549c2b | 2026-01-08 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| 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 |
| 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 |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | Cintex Services, LLC | 214ff8a6-179f-b907-e063-6394a90adcb1 | 2024-09-04 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | NuCare Pharmaceuticals,Inc. | 9910ec80-e37c-6a83-e053-2995a90a8237 | 2024-06-20 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | Cintex Services, LLC | 0fa3302e-b2b4-6b9b-e063-6394a90abc2c | 2024-01-23 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Bausch & Lomb Incorporated | 6c1b2658-e756-4f31-9bc8-f99a0baa4637 | 2023-08-31 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Padagis Israel Pharmaceuticals Ltd | 4fb4d39a-330e-4c84-abbc-3b33b36b206f | 2023-04-01 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Asclemed USA, Inc. | c4c29e13-8303-4a9a-bb47-d7413eaf2f26 | 2022-10-12 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Proficient Rx LP | 2b4f125c-338e-479f-8feb-b82324230c65 | 2022-08-01 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| SULFACETAMIDE SODIUM | SULFACETAMIDE SODIUM | KMM Pharmaceuticals, LLC | cdb5b3dc-9f75-85b7-e053-2a95a90a380c | 2022-02-14 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| PLEXION NS | SULFACETAMIDE SODIUM | Eckson Labs, LLC | cdb4c921-e671-6f06-e053-2995a90abd1e | 2022-02-10 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Asclemed USA, Inc. | 129d5dd9-32a4-4398-862d-820cd4468448 | 2020-10-24 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
| Klaron | SULFACETAMIDE SODIUM | Bausch Health US, LLC | 66ab38ea-5cea-47be-97f2-486517999fb0 | 2020-08-31 | Warnings, Adverse reactions | SULFACETAMIDE SODIUM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.