Application 217695
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 0.5MG | No | No |
| 002 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 0.75MG | No | No |
| 003 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 1MG | No | No |
| 004 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 1.5MG | No | No |
| 005 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 2MG | No | No |
| 006 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 4MG | No | No |
| 007 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 6MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217695-001 | DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | |
| A217695-002 | DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | |
| A217695-003 | DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | |
| A217695-004 | DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | |
| A217695-005 | DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | |
| A217695-006 | DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2023-08-23 | |
| A217695-007 | DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2023-08-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217695-001 | AB |
| A217695-002 | AB |
| A217695-003 | AB |
| A217695-004 | AB |
| A217695-005 | AB |
| A217695-006 | AB |
| A217695-007 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A217695-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217695-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217695-003 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217695-004 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217695-005 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217695-006 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A217695-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2023-08-23 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-003 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-004 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-005 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-006 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2023-08-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-003 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-004 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-005 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-006 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2023-08-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-003 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-004 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-005 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-006 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2023-08-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-003 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-004 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-005 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-006 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2023-08-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2023-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2023-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-003 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | 2023-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-004 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2023-08-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-005 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | 2023-08-23 | b8a1b40f171c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A217695-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217695-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217695-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217695-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217695-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217695-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A217695-007 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217695-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217695-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217695-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-005 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-006 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217695-007 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217695-005 | AB | 1 | b8a1b40f171c… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217695-003 | CGT | 2024-04-29 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217695-003 | CGT | 2024-04-29 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217695-003 | CGT | 2024-04-29 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217695-003 | CGT | 2024-04-29 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217695-003 | CGT | 2024-04-29 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A217695-003 | CGT | 2024-04-29 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A217695-003 | CGT | 2024-04-29 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A217695-003 | CGT | 2024-04-29 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A217695-003 | CGT | 2024-04-29 | 8072bd15b7f6… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A217695-003 | CGT | 2024-04-29 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A217695-003 | CGT | 2024-04-29 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A217695-003 | CGT | 2024-04-29 | ea1830bbd6c7… |
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 |
|---|---|---|---|---|---|---|
| Dexamethasone | DEXAMETHASONE | Sportpharm LLC | 12d19271-867b-41ae-a6d2-7e8de3637011 | 2026-04-24 | Warnings, Adverse reactions | 217695 ANDA217695 |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | b3217057-5945-452c-aa99-ab696fd8b5e7 | 2026-02-04 | Warnings, Adverse reactions | 217695 ANDA217695 |
| Dexamethasone | DEXAMETHASONE | Apotex Corp. | bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2 | 2025-09-17 | Warnings, Adverse reactions | 217695 ANDA217695 |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 3f2fe98a-ab42-4bec-bf97-c090567f9ad6 | 2025-04-01 | Warnings, Adverse reactions | 217695 ANDA217695 |