Application 083263
- Type
- ANDA
- Sponsor
- HOSPIRA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ALCOHOL 5% IN D5-W | ALCOHOL; DEXTROSE | INJECTABLE;INJECTION | 5ML/100ML;5GM/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 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC ยท 3 captures of this ZIP | 2021-05 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A083263-001 | ALCOHOL 5% IN D5-W | 5ML/100ML;5GM/100ML | INJECTABLE / INJECTION | Approved before 1982 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.