Application 217696

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	2MG	No	No

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

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
A217696-001	DEXAMETHASONE	DEXAMETHASONE	2MG	TABLET / ORAL	AB		2023-05-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217696-001	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217696-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	2023-05-09	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A217696-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217696-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217696-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217696-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217696-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217696-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217696-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217696-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217696-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217696-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217696-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217696-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217696-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217696-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A217696-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A217696-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A217696-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A217696-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A217696-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A217696-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A217696-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A217696-001	AB	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Direct_Rx	0a0db8e7-8474-3d08-e063-6294a90af3f5	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696
Dexamethasone	DEXAMETHASONE	NorthStar Rx LLC	05c77a4c-c508-babd-e063-6294a90a450a	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	fe8cf911-84ef-47be-acb8-0501b546299b	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217696 application number: ANDA217696