Application 220320
- Type
- NDA
- Sponsor
- MAP77
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ATONCY | ATOMOXETINE HYDROCHLORIDE | SOLUTION;ORAL | EQ 4MG BASE/ML | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N220320-001 | ATONCY | ATOMOXETINE HYDROCHLORIDE | EQ 4MG BASE/ML | SOLUTION / ORAL | RLD, RS | 2026-03-20 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N220320-001 | ATONCY | EQ 4MG BASE/ML | SOLUTION / ORAL | RLD, RS | 2026-03-20 | 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 |
|---|---|---|---|---|---|---|
| Atomoxetine hydrochloride | ATOMOXETINE HYDROCHLORIDE | Advagen Pharma Ltd. | 16096e9c-2dcd-4c84-a1a8-1c85d6d6898c | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 220320 NDA220320 |
| ATONCY | ATOMOXETINE HYDROCHLORIDE | Validus Pharmaceuticals LLC | 72d3d8cf-7f3b-479e-bd9f-e204d4118517 | 2026-04-02 | Boxed warning, Warnings, Adverse reactions | 220320 NDA220320 |