Application 014694

Type: NDA
Sponsor: ASPEN GLOBAL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 20MG PHOSPHATE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS
N014694-002	HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N014694-003	HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982
N014694-004	HEXADROL	DEXAMETHASONE SODIUM PHOSPHATE	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	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 2 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	RLD, Approved before 1982	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N014694-004	HEXADROL	EQ 20MG PHOSPHATE/ML	INJECTABLE / INJECTION	Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N014694-002	HEXADROL	EQ 4MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N014694-003	HEXADROL	EQ 10MG PHOSPHATE/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	INJECTABLE / INJECTION	RLD, Approved before 1982	`c0c555d07b60…`

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 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	11f10a47-1c42-40e4-89d8-bb000fef497c	2026-09-09	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	9822a5c3-d3f1-4e0b-9963-32b22740e10e	2026-08-31	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone sodium phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Micro Labs Limited	c6f2563b-5a39-48bf-bcfe-71dd417bd970	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ASCLEMED USA INC.	a31b013f-924c-42f8-b8ab-ce60bb8ad7b8	2026-08-07	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sagent Pharmaceuticals	4680d517-ed5a-4137-819c-122ee962a464	2026-08-06	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	a8aee11f-c928-41ef-8df8-e6d8b355536c	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	cca2c160-9188-48e8-9505-49a52388dcb7	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	7cbd9005-7df2-47ee-adb3-7244c1c69bc3	2026-06-30	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	2b626a48-c7aa-4443-9164-a08ff069ccd1	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health 107, LLC	6d3cbd54-93ef-40fe-b15a-7a4f52dc5f71	2026-05-29	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	6c7ff5f7-5688-4fc4-9194-9e6b8e6fab59	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health 107, LLC	7a7ee007-cd02-4f3f-8f0f-82c4964da6e6	2026-04-21	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	1596a3b4-8c2c-41b4-b1eb-af09863eaa13	2026-04-15	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	946f3c1d-0362-d602-e053-2995a90a3d9a	2026-03-23	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	56bdd2f3-ae94-4fd9-9d05-5b53263a09c1	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	6ea9e6ab-0d33-4635-9e98-aa2fbd8921cc	2026-03-16	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	fe464a39-7820-435c-9385-a4a96d8a38c8	2026-02-24	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	0e4f0f22-e6a1-4725-addb-0cc91bed07e9	2026-02-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Hikma Pharmaceuticals USA Inc.	0277cc0a-2fd4-4605-a310-b613be84ee26	2026-01-22	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	c464ffde-f64e-4716-92d2-720a10793248	2026-01-02	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE SODIUM PHOSPHATE

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
78714	SUPPL	2024-06-07
78681	SUPPL	2024-06-06
53935	ORIG	2018-05-01
52435	APPL	2018-02-06
33125	SUPPL	2014-07-17
384	SUPPL	2014-07-17