Application 217001

Type: ANDA
Sponsor: BIONPHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	4MG	No	No
002	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	6MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A217001-001	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2023-04-19
A217001-002	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB		2023-04-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A217001-001	AB
A217001-002	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A217001-001	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2023-04-19	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217001-002	DEXAMETHASONE	6MG	TABLET / ORAL	AB		2023-04-19	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A217001-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A217001-002	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Sportpharm LLC	a37486b9-4323-41fc-ac7e-869d95dc9568	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	2025-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Advanced Rx of Tennessee, LLC	348f5a56-978d-4272-e063-6294a90afdb6	2025-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	3166db4f-66a5-496a-a194-3cc01b7347d3	2025-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	b883860c-27ba-4bac-8ae3-4cf4d82d5071	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e652b041-2a0b-4bcd-a420-5d026302edbb	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217001 application number: ANDA217001