Application 220296
- Type
- ANDA
- Sponsor
- ASPIRO
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | INJECTABLE;INTRAVENOUS | EQ 50MG BASE/VIAL | No | No |
| 002 | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | INJECTABLE;INTRAVENOUS | EQ 100MG BASE/VIAL | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A220296-001 | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2026-03-17 | |
| A220296-002 | MICAFUNGIN SODIUM | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2026-03-17 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A220296-001 | AP |
| A220296-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A220296-001 | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2026-03-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A220296-002 | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2026-03-17 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220296-001 | MICAFUNGIN SODIUM | EQ 50MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2026-03-17 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220296-002 | MICAFUNGIN SODIUM | EQ 100MG BASE/VIAL | INJECTABLE / INTRAVENOUS | AP | 2026-03-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A220296-001 | AP | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A220296-002 | AP | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220296-001 | AP | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A220296-002 | 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 |
|---|---|---|---|---|---|---|
| Micafungin | MICAFUNGIN SODIUM | Sagent Pharmaceuticals | 33e579c1-b315-44cb-a690-e2dd2cdf44ee | 2025-11-08 | Warnings, Adverse reactions | MICAFUNGIN SODIUM |
| Micafungin | MICAFUNGIN SODIUM | Fresenius Kabi USA, LLC | dc5241be-4b85-4f04-8553-9819603373b8 | 2025-10-23 | Warnings, Adverse reactions | MICAFUNGIN SODIUM |
| Micafungin | MICAFUNGIN SODIUM | Hikma Pharmaceuticals USA Inc. | 8ba6f80c-05f0-4d75-930c-c8458db2e1c1 | 2025-08-22 | Warnings, Adverse reactions | MICAFUNGIN SODIUM |
| Micafungin | MICAFUNGIN SODIUM | Fresenius Kabi USA, LLC | f8198836-4011-40b9-af25-466ae08727f8 | 2024-10-09 | Warnings, Adverse reactions | MICAFUNGIN SODIUM |
| Micafungin | MICAFUNGIN SODIUM | Meitheal Pharmaceuticals Inc. | 579ff093-0359-4e0e-a6ea-2b6adac80bf0 | 2024-08-13 | Warnings, Adverse reactions | MICAFUNGIN SODIUM |
| Mycamine | MICAFUNGIN SODIUM | Astellas Pharma US, Inc. | a064c4a7-25ec-4a2c-afc2-703491a4a38b | 2020-07-23 | Warnings, Adverse reactions | MICAFUNGIN SODIUM |