Application 219569
- Type
- ANDA
- Sponsor
- INGENUS PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEHYDRATED ALCOHOL | DEHYDRATED ALCOHOL | SOLUTION;INTRA-ARTERIAL | 99% (5ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219569-001 | DEHYDRATED ALCOHOL | DEHYDRATED ALCOHOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | 2025-07-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219569-001 | AP |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219569-001 | DEHYDRATED ALCOHOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | 2025-07-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219569-001 | DEHYDRATED ALCOHOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | 2025-07-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219569-001 | DEHYDRATED ALCOHOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | 2025-07-09 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219569-001 | DEHYDRATED ALCOHOL | 99% (5ML) | SOLUTION / INTRA-ARTERIAL | AP | 2025-07-09 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A219569-001 | AP | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219569-001 | AP | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219569-001 | AP | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219569-001 | AP | 1 | 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 |
|---|---|---|---|---|---|---|
| Dehydrated Alcohol | ALCOHOL | Avenacy, LLC | 90e92d21-9821-4132-b17d-d98d523f12e8 | 2026-07-31 | Warnings, Adverse reactions | 219569 ANDA219569 |
| Dehydrated Alcohol | ALCOHOL | Solupharm Pharmazeutische Erzeugnisse GmbH | 372d3eb5-78ee-414c-a146-4a19e2266184 | 2025-12-17 | Warnings, Adverse reactions | 219569 ANDA219569 |
| Dehydrated Alcohol | DEHYDRATED ALCOHOL | Ingenus Pharmaceuticals, LLC | 1d5ec6f9-d58f-4651-a4a1-93fec13fd438 | 2025-07-11 | Warnings, Adverse reactions | 219569 ANDA219569 |