Application 219721
- Type
- ANDA
- Sponsor
- ANNORA PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 7.5MG | No | No |
| 002 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 15MG | No | No |
| 003 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 30MG | No | No |
| 004 | MIRTAZAPINE | MIRTAZAPINE | TABLET;ORAL | 45MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219721-001 | MIRTAZAPINE | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2025-10-02 | |
| A219721-002 | MIRTAZAPINE | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2025-10-02 | |
| A219721-003 | MIRTAZAPINE | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2025-10-02 | |
| A219721-004 | MIRTAZAPINE | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2025-10-02 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219721-001 | AB |
| A219721-002 | AB |
| A219721-003 | AB |
| A219721-004 | AB |
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 | A219721-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2025-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219721-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2025-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219721-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2025-10-02 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219721-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2025-10-02 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2025-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2025-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2025-10-02 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2025-10-02 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-001 | MIRTAZAPINE | 7.5MG | TABLET / ORAL | AB | 2025-10-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-002 | MIRTAZAPINE | 15MG | TABLET / ORAL | AB | 2025-10-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-003 | MIRTAZAPINE | 30MG | TABLET / ORAL | AB | 2025-10-02 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-004 | MIRTAZAPINE | 45MG | TABLET / ORAL | AB | 2025-10-02 | 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 | A219721-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219721-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219721-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219721-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219721-004 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219721-004 | AB | 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 |
|---|---|---|---|---|---|---|
| mirtazapine | MIRTAZAPINE | XLCare Pharmaceuticals Inc. | b6b31703-e77d-4d1a-b1ac-da972117e356 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 219721 ANDA219721 |
| mirtazapine | MIRTAZAPINE | A-S Medication Solutions | 222dfdde-6979-4b18-a7eb-ff1ad0a437c1 | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | 219721 ANDA219721 |
| mirtazapine | MIRTAZAPINE | Camber Pharmaceuticals, Inc. | b4b9b66e-87a1-4dbb-9eaf-71221bcb2265 | 2026-04-03 | Boxed warning, Warnings, Adverse reactions | 219721 ANDA219721 |