Application 204973
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 4MG | No | No |
| 002 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | TABLET, EXTENDED RELEASE;ORAL | 8MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204973-001 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-01-04 | |
| A204973-002 | FESOTERODINE FUMARATE | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-01-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204973-001 | AB |
| A204973-002 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A204973-001 | FESOTERODINE FUMARATE | 4MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-01-04 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A204973-002 | FESOTERODINE FUMARATE | 8MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-01-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A204973-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A204973-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fesoterodine Fumarate | FESOTERODINE FUMARATE | Alembic Pharmaceuticals Inc. | 299db62d-9658-4796-b449-657fa859c5cd | 2025-06-17 | Warnings, Adverse reactions | 204973 ANDA204973 62332-175 62332-176 |
| Fesoterodine Fumarate | FESOTERODINE FUMARATE | Alembic Pharmaceuticals Limited | 571147f2-e182-44b5-9d0b-ecfc3265cc2d | 2023-01-30 | Warnings, Adverse reactions | 204973 ANDA204973 |