Application 084614

Type: ANDA
Sponsor: ROXANE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	0.25MG	No	No

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
A084614-001	DEXAMETHASONE	DEXAMETHASONE	0.25MG	TABLET / ORAL		Approved before 1982

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	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A084614-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A084614-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084614-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084614-001	DEXAMETHASONE	0.25MG	TABLET / ORAL	Approved before 1982	`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 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	8c5375a7-7a0d-4af0-8b86-bc87698ac3d1	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Sportpharm LLC	a37486b9-4323-41fc-ac7e-869d95dc9568	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	f5c9b70b-b835-4f3b-9643-0aec50a0d3f2	2026-07-07	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Pangea Pharmaceuticals, LLC	a41e6e26-9ebb-4b06-866e-a24af21c644c	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	89e1d458-7caa-430f-9c54-360889899a73	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	736861fa-1df8-4afd-ba4a-dd7d7bffd865	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc	79b65fd4-16a5-42e0-b041-61d7bda0a5ff	2026-06-08	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	8deaaaf7-3efd-4065-b29f-e5ef038030f8	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	bf8acfdb-8dc8-4a69-90b0-33c680c421d6	2026-05-15	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	5622f8d2-1893-441b-8011-fa90c8a63b0b	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Sportpharm LLC	12d19271-867b-41ae-a6d2-7e8de3637011	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Pangea Pharmaceuticals, LLC	37607468-0331-44c0-9bb4-5c614c7b69d4	2026-04-19	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	4c619d48-8cf9-4085-8405-c8f066bce19c	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals, Inc.	c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd	2026-04-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
dexamethasone	DEXAMETHASONE	Major Pharmaceuticals	64b46398-9b97-45e8-b1ba-1a202d574448	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: dexamethasone generic name: DEXAMETHASONE
OZURDEX	DEXAMETHASONE	Allergan, Inc.	4b204f44-6e8a-4d17-803c-268f0b04679f	2026-03-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	NuCare Pharmaceuticals, Inc.	4a808dd5-35b7-e879-e063-6394a90a0bf7	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: DEXAMETHASONE generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	0a0db8e7-8474-3d08-e063-6294a90af3f5	2026-02-06	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e830be9d-0a8c-4712-93c6-284c208d6f0d	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	b3217057-5945-452c-aa99-ab696fd8b5e7	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE

Reported adverse events (FAERS/openFDA)#

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