Application 084612
- Type
- ANDA
- Sponsor
- HIKMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 4MG | No | No |
| 002 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 0.5MG | Yes | No |
| 003 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 0.75MG | Yes | No |
| 004 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 1MG | Yes | Yes |
| 005 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 1.5MG | Yes | No |
| 006 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 2MG | Yes | Yes |
| 007 | DEXAMETHASONE | DEXAMETHASONE | TABLET;ORAL | 6MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A084612-001 | DEXAMETHASONE | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-002 | DEXAMETHASONE | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-003 | DEXAMETHASONE | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-004 | DEXAMETHASONE | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 |
| A084612-005 | DEXAMETHASONE | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | |
| A084612-006 | DEXAMETHASONE | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | |
| A084612-007 | DEXAMETHASONE | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A084612-001 | AB |
| A084612-002 | AB |
| A084612-003 | AB |
| A084612-004 | AB |
| A084612-005 | AB |
| A084612-006 | AB |
| A084612-007 | 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 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-002 | DEXAMETHASONE | 0.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-003 | DEXAMETHASONE | 0.75MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-004 | DEXAMETHASONE | 1MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-005 | DEXAMETHASONE | 1.5MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-006 | DEXAMETHASONE | 2MG | TABLET / ORAL | AB | RLD, RS, Approved before 1982 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-007 | DEXAMETHASONE | 6MG | TABLET / ORAL | AB | RLD, RS | 1983-09-15 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A084612-001 | DEXAMETHASONE | 4MG | TABLET / ORAL | AB | RLD, Approved before 1982 | 5c6f7cd8ea54… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A084612-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-004 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-005 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-006 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A084612-007 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-005 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-006 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A084612-007 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-005 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-006 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A084612-007 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-005 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-006 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A084612-007 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A084612-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A084612-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A084612-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A084612-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A084612-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A084612-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A084612-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A084612-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A084612-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A084612-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A084612-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A084612-001 | AB | 1 | 5c6f7cd8ea54… |
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 | REMEDYREPACK INC. | f5c9b70b-b835-4f3b-9643-0aec50a0d3f2 | 2026-07-07 | Warnings, Adverse reactions | 084612 ANDA084612 70518-1534 |
| Dexamethasone | DEXAMETHASONE | PD-Rx Pharmaceuticals, Inc. | 89e1d458-7caa-430f-9c54-360889899a73 | 2026-06-12 | Warnings, Adverse reactions | 084612 ANDA084612 55289-582 |
| Dexamethasone | DEXAMETHASONE | Cardinal Health 107, LLC | bf8acfdb-8dc8-4a69-90b0-33c680c421d6 | 2026-05-15 | Warnings, Adverse reactions | 084612 ANDA084612 55154-4901 |
| Dexamethasone | DEXAMETHASONE | Northwind Health Company, LLC | aa30086a-8551-413e-9cf2-6393093cfcfd | 2025-12-26 | Warnings, Adverse reactions | 084612 ANDA084612 51655-012 |
| Dexamethasone | DEXAMETHASONE | Golden State Medical Supply, Inc. | a7455c92-41ce-4e87-e053-2995a90a610f | 2025-12-11 | Warnings, Adverse reactions | 084612 ANDA084612 51407-361 |
| Dexamethasone Intensol | DEXAMETHASONE INTENSOL | Hikma Pharmaceuticals USA, Inc. | b15200fb-1826-472b-a907-e677a272513b | 2025-06-06 | Warnings, Adverse reactions | 084612 ANDA084612 0054-4184 0054-8175 |
| DEXAMETHASONE | DEXAMETHASONE | Direct Rx | cc7140de-a205-f675-e053-2995a90ac22b | 2025-01-20 | Warnings, Adverse reactions | 084612 ANDA084612 72189-254 |
| Dexamethasone | DEXAMETHASONE | Proficient Rx LP | 99296e80-3ca6-4430-9ef7-adca357c31b3 | 2022-06-01 | Warnings, Adverse reactions | 084612 ANDA084612 63187-561 |
| Dexamethasone | DEXAMETHASONE | Doc Rx | f1c30431-554b-4161-9d8c-5795c689e0bd | 2021-06-11 | Warnings, Adverse reactions | 084612 ANDA084612 69306-114 |
| Dexamethasone | DEXAMETHASONE | Bryant Ranch Prepack | 89e570c9-3e64-433b-9779-b94332f2b5ef | 2020-02-25 | Warnings, Adverse reactions | 084612 ANDA084612 63629-3742 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0054-4184 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-4184 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-4184 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-4184 | Dexamethasone | Dexamethasone | Hikma Pharmaceuticals USA, Inc. | ANDA | Current |
| 0054-4184 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-8175 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-8175 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-8175 | Dexamethasone | Dexamethasone | West-Ward Pharmaceuticals Corp. | ANDA | Current |
| 0054-8175 | Dexamethasone | Dexamethasone | Hikma Pharmaceuticals USA, Inc. | ANDA | Current |
| 21695-382 | Dexamethasone | Dexamethasone | Rebel Distributors Corp | ANDA | Current |
| 45865-989 | Dexamethasone | Dexamethasone | medsource pharmaceuticals | ANDA | Current |
| 49999-059 | Dexamethasone | Dexamethasone | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-059 | Dexamethasone | Dexamethasone | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-059 | Dexamethasone | Dexamethasone | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-059 | Dexamethasone | Dexamethasone | Lake Erie Medical DBA Qua | ANDA | Current |
| 50090-0088 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0088 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0088 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0088 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0089 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0089 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0089 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 50090-0089 | Dexamethasone | Dexamethasone | A-S Medication Solutions | ANDA | Current |
| 51407-361 | Dexamethasone | Dexamethasone | Golden State Medical Supply | ANDA | Current |
| 51407-361 | Dexamethasone | Dexamethasone | Golden State Medical Supply | ANDA | Current |
| 51407-361 | Dexamethasone | Dexamethasone | Golden State Medical Supply, Inc. | ANDA | Current |
| 51655-012 | Dexamethsone | Dexamethasone | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 53217-374 | Dexamethasone | Dexamethasone | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55154-4901 | Dexamethasone | Dexamethasone | Cardinal Health | ANDA | Current |
| 55154-4901 | Dexamethasone | Dexamethasone | Cardinal Health 107, LLC | ANDA | Current |
| 55154-4901 | Dexamethasone | Dexamethasone | Cardinal Health | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-582 | Dexamethasone | Dexamethasone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 63187-561 | Dexamethasone | Dexamethasone | Proficient Rx LP | ANDA | Current |
| 63187-561 | Dexamethasone | Dexamethasone | Proficient Rx LP | ANDA | Current |
| 63187-561 | Dexamethasone | Dexamethasone | Proficient Rx LP | ANDA | Current |
| 63187-561 | Dexamethasone | Dexamethasone | Proficient Rx LP | ANDA | Current |
| 63187-561 | Dexamethasone | Dexamethasone | Proficient Rx LP | ANDA | Current |
| 63629-3742 | Dexamethasone | Dexamethasone | Bryant Ranch Prepack | ANDA | Current |
| 63629-3742 | Dexamethasone | Dexamethasone | Bryant Ranch Prepack | ANDA | Current |
| 66336-479 | Dexamethasone | Dexamethasone | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-0326 | Dexamethasone | Dexamethasone | RedPharm Drug | ANDA | Current |
| 67296-0326 | Dexamethasone | Dexamethasone | RedPharm Drug | ANDA | Current |
| 67296-0326 | Dexamethasone | Dexamethasone | RedPharm Drug | ANDA | Current |
| 68071-2321 | Dexamethasone | Dexamethasone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2321 | Dexamethasone | Dexamethasone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7142 | Dexamethasone | Dexamethasone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7142 | Dexamethasone | Dexamethasone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7142 | Dexamethasone | Dexamethasone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7142 | Dexamethasone | Dexamethasone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7142 | Dexamethasone | Dexamethasone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 69306-114 | Dexamethasone | Dexamethasone | Doc Rx | ANDA | Current |
| 69306-114 | Dexamethasone | Dexamethasone | Doc Rx | ANDA | Current |
| 69306-114 | Dexamethasone | Dexamethasone | Doc Rx | ANDA | Current |
| 70518-1534 | Dexamethasone | Dexamethasone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1534 | Dexamethasone | Dexamethasone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1534 | Dexamethasone | Dexamethasone | REMEDYREPACK INC. | ANDA | Current |
| 70518-1534 | Dexamethasone | Dexamethasone | REMEDYREPACK INC. | ANDA | Current |
| 72189-254 | DEXAMETHASONE | DEXAMETHASONE | Direct Rx | ANDA | Current |