Application 219130
- Type
- NDA
- Sponsor
- ALMATICA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ESCITALOPRAM | ESCITALOPRAM OXALATE | CAPSULE;ORAL | EQ 15MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N219130-001 | ESCITALOPRAM | ESCITALOPRAM OXALATE | EQ 15MG BASE | CAPSULE / ORAL | RLD, RS | 2025-08-29 |
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 | N219130-001 | ESCITALOPRAM | EQ 15MG BASE | CAPSULE / ORAL | RLD, RS | 2025-08-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N219130-001 | ESCITALOPRAM | EQ 15MG BASE | CAPSULE / ORAL | RLD, RS | 2025-08-29 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N219130-001 | ESCITALOPRAM | EQ 15MG BASE | CAPSULE / ORAL | RLD, RS | 2025-08-29 | 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 |
|---|---|---|---|---|---|---|
| escitalopram | ESCITALOPRAM | Almatica Pharma LLC | c0401570-a3b0-bef2-7365-c23dc952b8b6 | 2025-08-31 | Boxed warning, Warnings, Adverse reactions | 219130 NDA219130 |