Application 088448

Type: ANDA
Sponsor: ABRAXIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	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
A088448-001	DEXAMETHASONE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION			1984-01-25

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088448-001	DEXAMETHASONE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-01-25	`f41ea6bd6efb…`

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 2 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	6c7ff5f7-5688-4fc4-9194-9e6b8e6fab59	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Sportpharm LLC	12d19271-867b-41ae-a6d2-7e8de3637011	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health 107, LLC	7a7ee007-cd02-4f3f-8f0f-82c4964da6e6	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Pangea Pharmaceuticals, LLC	37607468-0331-44c0-9bb4-5c614c7b69d4	2026-04-19	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	1596a3b4-8c2c-41b4-b1eb-af09863eaa13	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	4c619d48-8cf9-4085-8405-c8f066bce19c	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: dexamethasone
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals, Inc.	c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
dexamethasone	DEXAMETHASONE	Major Pharmaceuticals	64b46398-9b97-45e8-b1ba-1a202d574448	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	946f3c1d-0362-d602-e053-2995a90a3d9a	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	56bdd2f3-ae94-4fd9-9d05-5b53263a09c1	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	6ea9e6ab-0d33-4635-9e98-aa2fbd8921cc	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	fe464a39-7820-435c-9385-a4a96d8a38c8	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE	DEXAMETHASONE	NuCare Pharmaceuticals, Inc.	4a808dd5-35b7-e879-e063-6394a90a0bf7	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	0a0db8e7-8474-3d08-e063-6294a90af3f5	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e830be9d-0a8c-4712-93c6-284c208d6f0d	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	b3217057-5945-452c-aa99-ab696fd8b5e7	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	0e4f0f22-e6a1-4725-addb-0cc91bed07e9	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Hikma Pharmaceuticals USA Inc.	0277cc0a-2fd4-4605-a310-b613be84ee26	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	64577454-d49e-4180-99e6-8461f74b0221	2026-01-20	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
DEXAMETHASONE	DEXAMETHASONE	Bryant Ranch Prepack	075717e3-be2a-4bb3-bead-492761bfb287	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.