Application 212138
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EMPAGLIFLOZIN | EMPAGLIFLOZIN | TABLET;ORAL | 10MG | No | No |
| 002 | EMPAGLIFLOZIN | EMPAGLIFLOZIN | TABLET;ORAL | 25MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A212138-001 | EMPAGLIFLOZIN | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | ||
| A212138-002 | EMPAGLIFLOZIN | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2022-08-03 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | AB | 2022-08-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2022-08-03 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | AB | 2022-08-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2022-08-03 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | AB | 2022-08-03 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | AB | 2022-08-03 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | AB | 2022-08-03 | e64feba35796… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212138-001 | EMPAGLIFLOZIN | 10MG | TABLET / ORAL | 2022-08-03 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A212138-002 | EMPAGLIFLOZIN | 25MG | TABLET / ORAL | 2022-08-03 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2023-01-26 05:58 UTC | 2023-01 | A212138-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A212138-002 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212138-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A212138-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A212138-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A212138-002 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A212138-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A212138-002 | AB | 1 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Jardiance | EMPAGLIFLOZIN | Redpharm Drug | 59ed43d9-b4e0-72a2-e063-6394a90a327d | 2026-08-26 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| Jardiance | EMPAGLIFLOZIN | Aphena Pharma Solutions - Tennessee, LLC | 334f1b3d-5670-6685-e063-6294a90a7e47 | 2026-06-17 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| Jardiance | EMPAGLIFLOZIN | Cardinal Health 107, LLC | 5777b8a8-ada6-4950-8548-43a1de11f075 | 2026-02-17 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| Jardiance | EMPAGLIFLOZIN | Boehringer Ingelheim Pharmaceuticals, Inc. | faf3dd6a-9cd0-39c2-0d2e-232cb3f67565 | 2026-01-30 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| Jardiance | EMPAGLIFLOZIN | Aphena Pharma Solutions - Tennessee, LLC | 8b6261f6-4bdc-462e-8af1-4064664c62f3 | 2025-10-27 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| Jardiance | EMPAGLIFLOZIN | A-S Medication Solutions | a77214ca-572e-485e-aae9-f7950187e5fb | 2023-08-08 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| JARDIANCE | EMPAGLIFLOZIN | A-S Medication Solutions | 942a82a4-cbbd-4e44-9965-8d03f767912b | 2023-07-24 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| JARDIANCE | EMPAGLIFLOZIN | A-S Medication Solutions | 1782b947-4a72-4feb-a488-1469d9af82bd | 2023-05-03 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
| JARDIANCE | EMPAGLIFLOZIN | A-S Medication Solutions | f2b41c77-0abb-40ee-8578-86a748d0e19e | 2023-05-03 | Warnings, Adverse reactions | EMPAGLIFLOZIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 63103 | ORIG | 2020-05-19 |