Application 011963
- Type
- NDA
- Sponsor
- WYETH PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | FOR SOLUTION;OPHTHALMIC | 0.125% | Yes | Yes |
| 002 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | FOR SOLUTION;OPHTHALMIC | 0.03% | No | No |
| 003 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | FOR SOLUTION;OPHTHALMIC | 0.25% | No | No |
| 004 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | FOR SOLUTION;OPHTHALMIC | 0.06% | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N011963-001 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.125% | FOR SOLUTION / OPHTHALMIC | RLD, RS, Approved before 1982 | ||
| N011963-002 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.03% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | ||
| N011963-003 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.25% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | ||
| N011963-004 | PHOSPHOLINE IODIDE | ECHOTHIOPHATE IODIDE | 0.06% | FOR SOLUTION / 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | N011963-001 | PHOSPHOLINE IODIDE | 0.125% | FOR SOLUTION / OPHTHALMIC | RLD, RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N011963-002 | PHOSPHOLINE IODIDE | 0.03% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N011963-003 | PHOSPHOLINE IODIDE | 0.25% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N011963-004 | PHOSPHOLINE IODIDE | 0.06% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N011963-001 | PHOSPHOLINE IODIDE | 0.125% | FOR SOLUTION / OPHTHALMIC | RLD, RS, Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N011963-002 | PHOSPHOLINE IODIDE | 0.03% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N011963-003 | PHOSPHOLINE IODIDE | 0.25% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N011963-004 | PHOSPHOLINE IODIDE | 0.06% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N011963-001 | PHOSPHOLINE IODIDE | 0.125% | FOR SOLUTION / OPHTHALMIC | RLD, RS, Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N011963-002 | PHOSPHOLINE IODIDE | 0.03% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N011963-003 | PHOSPHOLINE IODIDE | 0.25% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N011963-004 | PHOSPHOLINE IODIDE | 0.06% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N011963-001 | PHOSPHOLINE IODIDE | 0.125% | FOR SOLUTION / OPHTHALMIC | RLD, RS, Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N011963-002 | PHOSPHOLINE IODIDE | 0.03% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N011963-003 | PHOSPHOLINE IODIDE | 0.25% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N011963-004 | PHOSPHOLINE IODIDE | 0.06% | FOR SOLUTION / OPHTHALMIC | Approved before 1982 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Phospholine Iodide | ECHOTHIOPHATE IODIDE FOR OPHTHALMIC SOLUTION | Fera Pharmaceuticals, LLC | 8afc8951-db76-4f27-8752-7c0d6aa47244 | 2025-07-07 | Warnings, Adverse reactions | 011963 NDA011963 48102-053 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0046-1065 | Phospholine Iodide | echothiophate iodide | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-1065 | Phospholine Iodide | echothiophate iodide | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-1065 | Phospholine Iodide | echothiophate iodide | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-1065 | Phospholine Iodide | echothiophate iodide | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-1065 | Phospholine Iodide | echothiophate iodide | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 0046-1065 | Phospholine Iodide | echothiophate iodide | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | NDA | Current |
| 48102-053 | Phospholine Iodide | echothiophate iodide for ophthalmic solution | Fera Pharmaceuticals, LLC | NDA | Current |