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 5 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Prasco Laboratories	bfce6b49-f7ff-4ec7-9580-b730f0a207d7	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Redpharm Drug, Inc.	115e1bfb-1697-d567-e063-6394a90a78e5	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Direct_Rx	e90cb7f5-5e99-fbf3-e053-2995a90a70aa	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Direct_Rx	fade983c-81fb-df94-e053-6394a90a7560	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Direct_Rx	044d7898-4ab6-a0b3-e063-6294a90acdba	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	cc7140de-a205-f675-e053-2995a90ac22b	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	955db121-79f4-47eb-8c10-01b2d8b411e4	2025-01-13	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	3c05089c-5a25-40c3-9abc-b2e40696bcdc	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Somerset Therapeutics, LLC	2dcbf312-6f4b-439a-8e2f-dda61eeb2cab	2025-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	9a426a16-19f8-567e-e053-2a95a90a0a5b	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Advanced Rx Pharmacy of Tennessee, LLC	f4d6c7c8-7a77-6a46-e053-2995a90a4411	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	fa16db27-3c8c-eb22-e053-6394a90add59	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Civica, Inc.	d54a27f2-2af8-4f86-a7fd-453f6b1a9997	2024-12-26	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Somerset Therapeutics, LLC	799028e2-c0e4-494f-89ff-1b786babc34a	2024-12-19	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	4fedef4f-ec96-4f36-b2f0-01e243e3b89e	2024-10-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	df77fab1-f58c-46db-e053-2a95a90a5416	2024-10-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e652b041-2a0b-4bcd-a420-5d026302edbb	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Direct_rx	214dea63-d77a-922a-e063-6294a90a967e	2024-09-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Amneal Pharmaceuticals LLC	ddc82c42-2e6e-42a6-a30a-e41978e2f4da	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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