Application 216282
- Type
- ANDA
- Sponsor
- ZYDUS LIFESCIENCES
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 | 1.5MG | No | No |
| 004 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 4MG | No | No |
| 005 | 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 |
|---|---|---|---|---|---|---|---|
| A216282-001 | DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | |
| A216282-002 | DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | |
| A216282-003 | DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | |
| A216282-004 | DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | |
| A216282-005 | DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216282-001 | AB |
| A216282-002 | AB |
| A216282-003 | AB |
| A216282-004 | AB |
| A216282-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-001 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | 2024-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-002 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | 2024-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-003 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | 2024-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-004 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | 2024-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-005 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | 2024-02-07 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A216282-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216282-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216282-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216282-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216282-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216282-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216282-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216282-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216282-005 | AB | 1 | 5bbf6a4d5a75… |
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 | Preferred Pharmaceuticals Inc | 79b65fd4-16a5-42e0-b041-61d7bda0a5ff | 2026-06-08 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | REMEDYREPACK INC. | 8deaaaf7-3efd-4065-b29f-e5ef038030f8 | 2026-06-01 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | e830be9d-0a8c-4712-93c6-284c208d6f0d | 2026-02-05 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | Preferred Pharmaceuticals Inc. | 64577454-d49e-4180-99e6-8461f74b0221 | 2026-01-20 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | a5609df4-4933-4f85-a7b8-bc54a70a2bac | 2025-04-30 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | Direct_rx | 214dea63-d77a-922a-e063-6294a90a967e | 2024-09-04 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | Viona Pharmaceuticals Inc | 93bb34a7-c8ca-4dab-b2a0-cbe011e1090c | 2024-03-30 | Warnings, Adverse reactions | 216282 ANDA216282 |
| Dexamethasone | DEXAMETHASONE | Zydus Lifesciences Limited | 522a1a49-5540-4245-a15f-e3cdc0a97a5e | 2024-03-30 | 216282 ANDA216282 |