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 4 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	45fd8030-dbe3-4da4-9d0a-6549cf4f7359	2024-07-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	710ce0fc-78b3-402d-a2ca-e5eda09f3211	2024-06-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	c75360d3-2e4f-4620-a8f0-db28b1aa704b	2024-05-28	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	e9012a11-6219-4272-aea2-b7328bbcf523	2024-05-13		Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	360d3af0-8f69-4e82-ab5f-1f70cc2025d4	2024-05-13	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	17f56402-331e-2e3d-e063-6394a90acc0e	2024-05-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	36f104ba-80b4-4713-aa74-f80483b7bded	2024-04-03	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	93bb34a7-c8ca-4dab-b2a0-cbe011e1090c	2024-03-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	1e84a609-22a0-41b9-83a0-c45019c8cf9a	2024-03-30		Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Zydus Lifesciences Limited	522a1a49-5540-4245-a15f-e3cdc0a97a5e	2024-03-30		Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Viona Pharmaceuticals Inc	86afd383-7d6b-48f0-a803-9446fa1ded10	2024-03-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Chartwell RX, LLC	3746066a-3c87-4238-945a-6dfb4d01a072	2024-03-14	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	NorthStar Rx LLC	05c77a4c-c508-babd-e063-6294a90a450a	2024-03-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	fe8cf911-84ef-47be-acb8-0501b546299b	2024-03-04	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
dexamethasone	DEXAMETHASONE	Amneal Pharmaceuticals NY LLC	ac71f888-c83a-46a5-921c-1ebdf6cfadc1	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
dexamethasone	DEXAMETHASONE	Amneal Pharmaceuticals NY LLC	b9eb9a30-c1da-4d38-8ea8-616a254e2afc	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Alvogen Inc.	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	2024-02-21	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	3ff06262-4c6f-4423-99fa-b4d8191ea133	2024-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	6f917c55-034a-40c5-9011-0e10e94d0eba	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	99296e80-3ca6-4430-9ef7-adca357c31b3	2022-06-01	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