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 6 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	Amneal Pharmaceuticals LLC	ba18ba23-9ea3-4ce1-84ae-74e9151bb6a4	2024-07-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	45fd8030-dbe3-4da4-9d0a-6549cf4f7359	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Gland Pharma Limited	c9d9ab76-6bc6-433d-aad7-8d49064ed745	2024-06-26	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Phlow Corporation	02d25ab8-8f51-452b-b944-f569fbae36fe	2024-06-25	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	710ce0fc-78b3-402d-a2ca-e5eda09f3211	2024-06-11	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	18a70010-6cc5-19e2-e063-6394a90a0ea6	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	c75360d3-2e4f-4620-a8f0-db28b1aa704b	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	e9012a11-6219-4272-aea2-b7328bbcf523	2024-05-13		Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	360d3af0-8f69-4e82-ab5f-1f70cc2025d4	2024-05-13	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	17f56402-331e-2e3d-e063-6394a90acc0e	2024-05-08	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	d21f3055-8a8a-4797-93e2-c8f582cbdae1	2024-04-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	36f104ba-80b4-4713-aa74-f80483b7bded	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	93bb34a7-c8ca-4dab-b2a0-cbe011e1090c	2024-03-30	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	1e84a609-22a0-41b9-83a0-c45019c8cf9a	2024-03-30		Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	522a1a49-5540-4245-a15f-e3cdc0a97a5e	2024-03-30		Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	86afd383-7d6b-48f0-a803-9446fa1ded10	2024-03-29	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	Chartwell RX, LLC	3746066a-3c87-4238-945a-6dfb4d01a072	2024-03-14	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone	DEXAMETHASONE	NorthStar Rx LLC	05c77a4c-c508-babd-e063-6294a90a450a	2024-03-08	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	dff598e8-e662-411f-978d-4ba3fb8ef7db	2024-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	fe8cf911-84ef-47be-acb8-0501b546299b	2024-03-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone

Reported adverse events (FAERS/openFDA)#

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