Application 012675

Type: NDA
Sponsor: ASPEN GLOBAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
004	HEXADROL	DEXAMETHASONE	TABLET;ORAL	0.5MG	No	No
007	HEXADROL	DEXAMETHASONE	TABLET;ORAL	0.75MG	No	No
009	HEXADROL	DEXAMETHASONE	TABLET;ORAL	1.5MG	No	No
010	HEXADROL	DEXAMETHASONE	TABLET;ORAL	4MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N012675-004	HEXADROL	DEXAMETHASONE	0.5MG	TABLET / ORAL	Approved before 1982
N012675-007	HEXADROL	DEXAMETHASONE	0.75MG	TABLET / ORAL	Approved before 1982
N012675-009	HEXADROL	DEXAMETHASONE	1.5MG	TABLET / ORAL	Approved before 1982
N012675-010	HEXADROL	DEXAMETHASONE	4MG	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 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012675-004	HEXADROL	0.5MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012675-007	HEXADROL	0.75MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012675-009	HEXADROL	1.5MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012675-010	HEXADROL	4MG	TABLET / ORAL	Approved before 1982	`5bbf6a4d5a75…`

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 5 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Doc Rx	f1c30431-554b-4161-9d8c-5795c689e0bd	2021-06-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	35307d74-aed8-4c6b-9568-2223a4f350bd	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	a9fd2013-0797-4ec4-82c5-07d282522625	2020-09-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	2020-03-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	89e570c9-3e64-433b-9779-b94332f2b5ef	2020-02-25	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
TaperDex 12-day	DEXAMETHASONE	Proficient Rx LP	d66e36d3-f6f8-4fa8-84fb-7717463e37b3	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78711	SUPPL	2024-06-07
78678	SUPPL	2024-06-06