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 3 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Advanced Rx of Tennessee, LLC	348f5a56-978d-4272-e063-6294a90afdb6	2025-05-07	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
MAXIDEX	DEXAMETHASONE	Harrow Eye, LLC	35e47fcd-e020-43e5-8322-41f8060d220d	2025-05-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	a5609df4-4933-4f85-a7b8-bc54a70a2bac	2025-04-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Marlex Pharmaceuticals, Inc	7b51ffce-ec64-4b49-8870-b9666537c541	2025-04-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXTENZA	DEXAMETHASONE	Ocular Therapeutix, Inc.	7514e6b8-c33f-4fbf-8810-ef520e1eb4bd	2025-04-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	3f2fe98a-ab42-4bec-bf97-c090567f9ad6	2025-04-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	401ec088-984a-49ab-b317-747c2b9b9e22	2025-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bionpharma Inc.,	3166db4f-66a5-496a-a194-3cc01b7347d3	2025-03-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	b883860c-27ba-4bac-8ae3-4cf4d82d5071	2025-02-10	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Prasco Laboratories	bfce6b49-f7ff-4ec7-9580-b730f0a207d7	2025-02-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Redpharm Drug, Inc.	115e1bfb-1697-d567-e063-6394a90a78e5	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	e90cb7f5-5e99-fbf3-e053-2995a90a70aa	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	fade983c-81fb-df94-e053-6394a90a7560	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_Rx	044d7898-4ab6-a0b3-e063-6294a90acdba	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	Direct Rx	cc7140de-a205-f675-e053-2995a90ac22b	2025-01-20	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals Inc.	955db121-79f4-47eb-8c10-01b2d8b411e4	2025-01-13	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	fa16db27-3c8c-eb22-e053-6394a90add59	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	e652b041-2a0b-4bcd-a420-5d026302edbb	2024-09-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Direct_rx	214dea63-d77a-922a-e063-6294a90a967e	2024-09-04	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