Application 088252

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE INTENSOL	DEXAMETHASONE	CONCENTRATE;ORAL	1MG/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A088252-001	DEXAMETHASONE INTENSOL	DEXAMETHASONE	1MG/ML	CONCENTRATE / ORAL		RLD, RS	1983-09-01

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RS	1983-09-01	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A088252-001	DEXAMETHASONE INTENSOL	1MG/ML	CONCENTRATE / ORAL	RLD, RS	1983-09-01	`a50c72e98297…`

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 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Sportpharm LLC	77429dd3-e66d-4ab4-a3f3-5ae0b987ac17	2026-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088252 application number: ANDA088252
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088252 application number: ANDA088252 ndc (product): 0054-3176

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-3176	Dexamethasone Intensol	Dexamethasone Intensol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3176	Dexamethasone Intensol	Dexamethasone Intensol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3176	Dexamethasone Intensol	Dexamethasone Intensol	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-3176	Dexamethasone Intensol	Dexamethasone Intensol	Hikma Pharmaceuticals USA, Inc.	ANDA	Current
68151-5026	Dexamethasone Intensol	Dexamethasone Intensol	Carilion Materials Management	ANDA	Current