Application 012674

Type: NDA
Sponsor: ASPEN GLOBAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	HEXADROL	DEXAMETHASONE	ELIXIR;ORAL	0.5MG/5ML	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
N012674-001	HEXADROL	DEXAMETHASONE	0.5MG/5ML	ELIXIR / 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 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N012674-001	HEXADROL	0.5MG/5ML	ELIXIR / ORAL	Approved before 1982	`cb3db0bc1861…`

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 2 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DEXAMETHASONE	DEXAMETHASONE	Bryant Ranch Prepack	075717e3-be2a-4bb3-bead-492761bfb287	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Hemady	DEXAMETHASONE	Edenbridge Pharmaceuticals LLC.	6b9cf32c-6d60-4853-bbfd-2304ffc2c129	2026-01-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Northwind Health Company, LLC	aa30086a-8551-413e-9cf2-6393093cfcfd	2025-12-26	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Golden State Medical Supply, Inc.	a7455c92-41ce-4e87-e053-2995a90a610f	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	a8d6792e-757e-4dc6-adf5-0d9211075428	2025-12-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	5d9b22ca-c619-4ee3-98eb-74544d0d5cb3	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Kesin Pharma Corporation	43e2a24a-4465-5787-e063-6394a90a0b81	2025-11-18	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	Kanchan Healthcare Inc	02f7bf9c-1aa3-4734-8a3e-1f49498055d7	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	429d0d32-a1ff-481b-b4e9-c0b17b3610a1	2025-11-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	01cfaa3e-5e30-18fa-e063-6394a90a084e	2025-10-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
DEXAMETHASONE	DEXAMETHASONE	Advagen Pharma Ltd.	3c1729db-8ba3-4cba-9eff-ab4ae2c061c2	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	2ceb3a01-f5bb-4538-b5c1-cea400901d02	2025-10-15	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	8c5375a7-7a0d-4af0-8b86-bc87698ac3d1	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Apotex Corp.	bfaa71cb-e517-8d94-f64b-8cdbf7b8fbf2	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
dexamethasone	DEXAMETHASONE	Major Pharmaceuticals	5ec5b0e6-7fa8-4afc-97a4-d185484ada8b	2025-09-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Rising Pharma Holdings, Inc.	7cf5c17c-a80b-4547-83b2-0d53e2b933f7	2025-09-05	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	A-S Medication Solutions	16c59e9a-8e4f-4300-bbbb-bcc982c18fc8	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	A-S Medication Solutions	89af5591-eebf-44e7-827f-ce3b123123e4	2025-08-15	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	141e16a7-1f3d-3943-e063-6294a90ac5a9	2025-07-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78710	SUPPL	2024-06-07
78677	SUPPL	2024-06-06