Application 211560
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DAPAGLIFLOZIN | DAPAGLIFLOZIN | TABLET;ORAL | 5MG | No | No |
| 002 | DAPAGLIFLOZIN | DAPAGLIFLOZIN | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211560-001 | DAPAGLIFLOZIN | DAPAGLIFLOZIN | 5MG | TABLET / ORAL | AB | 2026-04-06 | |
| A211560-002 | DAPAGLIFLOZIN | DAPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2026-04-06 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211560-001 | AB |
| A211560-002 | AB |
Orange Book exclusivity#
| Application-product | Exclusivity code | Expiration |
|---|---|---|
| A211560-001 | PC | 2026-10-03 |
| A211560-002 | PC | 2026-10-03 |
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 | A211560-001 | DAPAGLIFLOZIN | 5MG | TABLET / ORAL | AB | 2026-04-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211560-002 | DAPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2026-04-06 | caaa826d4ba7… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211560-001 | DAPAGLIFLOZIN | 5MG | TABLET / ORAL | AB | 2026-04-06 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211560-002 | DAPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2026-04-06 | 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 | A211560-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211560-002 | AB | 1 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211560-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211560-002 | AB | 1 | a50c72e98297… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A211560-001 | PC | 2026-10-03 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211560-002 | PC | 2026-10-03 | caaa826d4ba7… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211560-001 | PC | 2026-10-03 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211560-002 | PC | 2026-10-03 | 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 |
|---|---|---|---|---|---|---|
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | Alembic Pharmaceuticals Inc. | 840e2146-2383-489b-bcc4-fecfe986685a | 2026-06-23 | Warnings, Adverse reactions | 211560 ANDA211560 |
| DAPAGLIFLOZIN | DAPAGLIFLOZIN | Alembic Pharmaceuticals Limited | d44f7eed-dd51-40d1-8408-8fb331e1f1f6 | 2026-04-21 | Warnings, Adverse reactions | 211560 ANDA211560 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59598 | ORIG | 2019-08-06 |