Application 040491

Type: ANDA
Sponsor: FRESENIUS KABI USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 10MG PHOSPHATE/ML	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A040491-001	AP

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040491-001	DEXAMETHASONE SODIUM PHOSPHATE PRESERVATIVE FREE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	2003-04-11	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A040491-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040491-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040491-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040491-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040491-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040491-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040491-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040491-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040491-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040491-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040491-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040491-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040491-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040491-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040491-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040491-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040491-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040491-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040491-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040491-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040491-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040491-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040491-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040491-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040491-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040491-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040491-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040491-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040491-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040491-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040491-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040491-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040491-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040491-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040491-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040491-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040491-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040491-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040491-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040491-001	AP	1	`e64feba35796…`

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	cca2c160-9188-48e8-9505-49a52388dcb7	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491 ndc (product): 63323-506
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	7cbd9005-7df2-47ee-adb3-7244c1c69bc3	2026-06-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491 ndc (product): 63323-506
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	6c7ff5f7-5688-4fc4-9194-9e6b8e6fab59	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	56bdd2f3-ae94-4fd9-9d05-5b53263a09c1	2026-03-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040491 application number: ANDA040491

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2363	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	ANDA	Current
55154-9371	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health	ANDA	Current
63187-348	Dexlido-M Kit	Dexamethasone Sodium Phosphate, Lidocaine Hydrochloride, Bupivacaine Hydrochloride, Povidine Iodine	Proficient Rx LP	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
63323-506	Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Fresenius Kabi USA, LLC	ANDA	Current
69677-071	MAS CARE-PAK DEXAMETHASONE	Dexamethasone Sodium Phosphate	MAS Management Group Inc.	ANDA	Current
70112-555	TopiDex	dexamethasone surgical combo kit	Topicare Management, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
7669	SUPPL	2015-07-28
38897	SUPPL	2015-07-27