Home Applications 211451 Application 211451
Type ANDA
Sponsor HIKMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211451-001 DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01
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 table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION AP 2023-08-01 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A211451-001 DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML INJECTABLE / INJECTION 2023-08-01 a50c72e98297…
Observed Orange Book normalized TE history# 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.
Matched openFDA labels page 4 of 4 · 71 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE Medical Purchasing Solutions, LLC 8969803e-2e45-1f28-e053-2995a90a05a7 2023-05-15 Warnings, Adverse reactions Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE Medical Purchasing Solutions, LLC bbf0f0ee-1891-4f3d-e053-2a95a90a5e18 2023-05-04 Warnings, Adverse reactions Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE Medical Purchasing Solutions, LLC 9f69846e-5897-c301-e053-2a95a90a44f1 2023-05-03 Warnings, Adverse reactions Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE Medical Purchasing Solutions, LLC 667323ea-5a5e-3465-e053-2a91aa0a1667 2023-04-26 Warnings, Adverse reactions Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE Asclemed USA, Inc. 2d96d5e8-00bf-406b-b345-f1c31865fe94 2023-04-04 Warnings, Adverse reactions Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE HF Acquisition Co LLC, DBA HealthFirst 94cb045b-5801-db32-e053-2a95a90a93ef 2022-12-10 Warnings, Adverse reactions Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE DEXAMETHASONE SODIUM PHOSPHATE Asclemed USA, Inc. ca762fbf-6bf5-4b39-8f40-3fb5f1f77778 2022-10-12 Warnings, Adverse reactions Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE Bausch & Lomb Incorporated 6bdcefbe-51e3-4ca4-afda-5aeca7b6fa73 2022-08-31 Warnings, Adverse reactions Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE Asclemed USA, Inc. b2ce414a-3b1f-4533-bb3a-18594529dead 2020-11-25 Warnings, Adverse reactions Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE DMT SUIK DEXAMETHASONE SODIUM PHOSPHATE Asclemed USA, Inc. a7b7884a-6bd4-4d06-8f14-0759450c0724 2020-06-17 Warnings, Adverse reactions Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE Dexamethasone Sodium Phosphate DEXAMETHASONE SODIUM PHOSPHATE Mylan Institutional LLC 836f8017-d023-410b-8515-ec776e73ca59 2019-11-04 Warnings, Adverse reactions Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.