Application 050356
- Type
- NDA
- Sponsor
- ENDO PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | COLY-MYCIN S | COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE | SUSPENSION/DROPS;OTIC | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050356-001 | COLY-MYCIN S | COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | SUSPENSION/DROPS / OTIC | RLD, RS, 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 | N050356-001 | COLY-MYCIN S | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | SUSPENSION/DROPS / OTIC | RLD, RS, Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N050356-001 | COLY-MYCIN S | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | SUSPENSION/DROPS / OTIC | RLD, RS, Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N050356-001 | COLY-MYCIN S | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | SUSPENSION/DROPS / OTIC | RLD, RS, Approved before 1982 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N050356-001 | COLY-MYCIN S | EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML | SUSPENSION/DROPS / OTIC | RLD, RS, 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 |
|---|---|---|---|---|---|---|
| Cortisporin TC | COLISTIN SULFATE, NEOMYCIN SULFATE, THONZONIUM BROMIDE AND HYDROCORTISONE ACETATE | Endo USA, Inc. | 9c6fc1c7-3350-42ae-b999-aca48e704bb1 | 2024-08-01 | Warnings, Adverse reactions | 050356 NDA050356 63481-529 |
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 |
|---|---|---|---|---|---|
| 63481-421 | Coly-Mycin S | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | Endo Pharmaceuticals, Inc. | NDA | Current |
| 63481-421 | Coly-Mycin S | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | Endo Pharmaceuticals Inc. | NDA | Current |
| 63481-529 | Cortisporin TC | colistin sulfate, neomycin sulfate, thonzonium bromide and hydrocortisone acetate | Endo Pharmaceuticals, Inc. | NDA | Current |