Application 080020
- Type
- ANDA
- Sponsor
- ALCON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | ISOPTO CETAMIDE | SULFACETAMIDE SODIUM | SOLUTION/DROPS;OPHTHALMIC | 15% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080020-002 | ISOPTO CETAMIDE | SULFACETAMIDE SODIUM | 15% | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A080020-002 | ISOPTO CETAMIDE | 15% | SOLUTION/DROPS / OPHTHALMIC | Approved before 1982 | e64feba35796… |
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 | 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 |
| Sulfacetamide Sodium | SULFACETAMIDE SODIUM | Preferred Pharmaceuticals, Inc | cf0cc763-49b5-435d-852b-e7617c8d3286 | 2025-09-24 | 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 |