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 4 of 8 · 151 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	2ceb3a01-f5bb-4538-b5c1-cea400901d02	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	d9b935d5-1b4f-4a08-8d40-57f397368fef	2025-09-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Apotex Corp.	bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2	2025-09-17	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
dexamethasone	DEXAMETHASONE	Major Pharmaceuticals	5ec5b0e6-7fa8-4afc-97a4-d185484ada8b	2025-09-08	Warnings, Adverse reactions	Name fallback brand name: dexamethasone
Dexamethasone	DEXAMETHASONE	Rising Pharma Holdings, Inc.	7cf5c17c-a80b-4547-83b2-0d53e2b933f7	2025-09-05	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	A-S Medication Solutions	16c59e9a-8e4f-4300-bbbb-bcc982c18fc8	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	A-S Medication Solutions	89af5591-eebf-44e7-827f-ce3b123123e4	2025-08-15	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	141e16a7-1f3d-3943-e063-6294a90ac5a9	2025-07-30	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Eugia US LLC	224c34c9-cadc-40cb-a9b7-a9772fd0208e	2025-07-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	36854dbc-22f2-5df9-e063-6394a90ad934	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Advanced Rx of Tennessee, LLC	348f5a56-978d-4272-e063-6294a90afdb6	2025-05-07	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	a5609df4-4933-4f85-a7b8-bc54a70a2bac	2025-04-30	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Marlex Pharmaceuticals, Inc	7b51ffce-ec64-4b49-8870-b9666537c541	2025-04-22	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Armas Pharmaceuticals	0ce0211c-86fa-4056-b161-0950639df6d8	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	3f2fe98a-ab42-4bec-bf97-c090567f9ad6	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	401ec088-984a-49ab-b317-747c2b9b9e22	2025-03-05	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	3166db4f-66a5-496a-a194-3cc01b7347d3	2025-03-05	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Somerset Therapeutics, LLC	5a1b0266-90c8-4176-a6b0-c4204d3c604e	2025-02-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	b883860c-27ba-4bac-8ae3-4cf4d82d5071	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone

Reported adverse events (FAERS/openFDA)#

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