Application 083483
- Type
- ANDA
- Sponsor
- MILES
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALCOHOL 5% IN DEXTROSE 5% | ALCOHOL | INJECTABLE;INJECTION | 5ML/100ML | No | No |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083483-001 | ALCOHOL 5% IN DEXTROSE 5% | 5ML/100ML | INJECTABLE / INJECTION | Approved before 1982 | ea99ee380514… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.