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 3 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	Henry Schein, Inc.	c464ffde-f64e-4716-92d2-720a10793248	2026-01-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	6ded4eac-3f86-4cf8-a05f-3e9c52984d6c	2026-01-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Northwind Health Company, LLC	aa30086a-8551-413e-9cf2-6393093cfcfd	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ce25183b-cd67-4997-8de9-df59b750883b	2025-12-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ProPharma Distribution	384206f5-75ed-9bd2-e063-6294a90a5038	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ProPharma Distribution	42c879cc-38dc-c9bc-e063-6294a90a204d	2025-12-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	4dd55929-fe0a-4884-ae0d-6f9435920eb7	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Golden State Medical Supply, Inc.	a7455c92-41ce-4e87-e053-2995a90a610f	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	88d25d19-acff-477b-86c8-9797782045b8	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	a8d6792e-757e-4dc6-adf5-0d9211075428	2025-12-09	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	5d9b22ca-c619-4ee3-98eb-74544d0d5cb3	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Kesin Pharma Corporation	43e2a24a-4465-5787-e063-6394a90a0b81	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Eugia US LLC	29947f67-7868-40af-8ad2-a61f7149b44c	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE	DEXAMETHASONE	Kanchan Healthcare Inc	02f7bf9c-1aa3-4734-8a3e-1f49498055d7	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Eugia US LLC	ce7ad5a4-a9c5-42d6-87cc-ca16556208d2	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DMT SUIK	DEXAMETHASONE SODIUM PHOSPHATE	Advanced Rx of Tennessee, LLC	43045630-8bf8-59ae-e063-6294a90a2ebe	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	2025-11-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	01cfaa3e-5e30-18fa-e063-6394a90a084e	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC.	41eb3b4a-3386-ebfa-e063-6394a90a4dba	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE	DEXAMETHASONE	Advagen Pharma Ltd.	3c1729db-8ba3-4cba-9eff-ab4ae2c061c2	2025-10-22	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE

Reported adverse events (FAERS/openFDA)#

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