Application 088522

Type: ANDA
Sponsor: INTL MEDICATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 20MG 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
A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION			1984-02-17

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	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A088522-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	1984-02-17	`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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	8969803e-2e45-1f28-e053-2995a90a05a7	2023-05-15	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	bbf0f0ee-1891-4f3d-e053-2a95a90a5e18	2023-05-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	9f69846e-5897-c301-e053-2a95a90a44f1	2023-05-03	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	667323ea-5a5e-3465-e053-2a91aa0a1667	2023-04-26	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	2d96d5e8-00bf-406b-b345-f1c31865fe94	2023-04-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	94cb045b-5801-db32-e053-2a95a90a93ef	2022-12-10	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	ca762fbf-6bf5-4b39-8f40-3fb5f1f77778	2022-10-12	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE SODIUM PHOSPHATE generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Bausch & Lomb Incorporated	6bdcefbe-51e3-4ca4-afda-5aeca7b6fa73	2022-08-31	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	b2ce414a-3b1f-4533-bb3a-18594529dead	2020-11-25	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE
DMT SUIK	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	a7b7884a-6bd4-4d06-8f14-0759450c0724	2020-06-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	836f8017-d023-410b-8515-ec776e73ca59	2019-11-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone Sodium Phosphate generic name: DEXAMETHASONE SODIUM PHOSPHATE

Reported adverse events (FAERS/openFDA)#

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