Application 040802

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	INJECTABLE;INJECTION	EQ 10MG PHOSPHATE/ML	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
A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP		2008-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040802-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040802-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	2008-08-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040802-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040802-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040802-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040802-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040802-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040802-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040802-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040802-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040802-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040802-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040802-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040802-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040802-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040802-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040802-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040802-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040802-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040802-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040802-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040802-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040802-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040802-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040802-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040802-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040802-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040802-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040802-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040802-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040802-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040802-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040802-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040802-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040802-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040802-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040802-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040802-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040802-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040802-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A040802-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A040802-001	AP	1	`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 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Sportpharm LLC	a8aee11f-c928-41ef-8df8-e6d8b355536c	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	6ded4eac-3f86-4cf8-a05f-3e9c52984d6c	2026-01-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802 ndc (product): 0404-9842
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	36854dbc-22f2-5df9-e063-6394a90ad934	2025-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	dff598e8-e662-411f-978d-4ba3fb8ef7db	2024-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802 ndc (product): 67457-420
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69339a97-99dd-7297-e053-2991aa0a7fb8	2023-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802 ndc (product): 71872-7090
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Mylan Institutional LLC	836f8017-d023-410b-8515-ec776e73ca59	2019-11-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040802 application number: ANDA040802 ndc (product): 67457-483

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0404-9842	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Henry Schein, Inc.	ANDA	Current
0404-9842	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Henry Schein, Inc.	ANDA	Current
52584-420	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-420	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-420	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-420	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
52584-420	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	General Injectables and Vaccines, Inc.	ANDA	Current
67457-420	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Mylan Institutional LLC	ANDA	Current
67457-483	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Mylan Institutional LLC	ANDA	Current
71872-7090	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7090	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current