Application 087702

Type: ANDA
Sponsor: WEST-WARD PHARMS INT

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	Yes

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
A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087702-001	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087702-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 10MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	RS	1982-09-07	`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	A087702-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087702-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087702-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087702-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087702-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087702-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087702-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087702-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087702-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087702-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087702-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087702-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087702-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087702-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087702-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087702-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087702-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087702-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087702-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087702-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087702-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087702-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087702-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087702-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087702-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087702-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087702-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087702-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087702-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087702-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087702-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087702-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087702-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087702-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087702-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087702-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087702-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087702-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087702-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087702-001	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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Cardinal Health 107, LLC	7a7ee007-cd02-4f3f-8f0f-82c4964da6e6	2026-04-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 55154-5118
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	6ea9e6ab-0d33-4635-9e98-aa2fbd8921cc	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 70518-0532
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	A-S Medication Solutions	0e4f0f22-e6a1-4725-addb-0cc91bed07e9	2026-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 50090-3541
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Hikma Pharmaceuticals USA Inc.	0277cc0a-2fd4-4605-a310-b613be84ee26	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 0641-0367
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Civica, Inc.	d54a27f2-2af8-4f86-a7fd-453f6b1a9997	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 72572-122
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	7da9da65-0c03-23e2-e053-2a91aa0a042f	2024-01-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 51662-1343
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	69344707-904d-7ba2-e053-2a91aa0a31f4	2023-05-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087702 application number: ANDA087702 ndc (product): 71872-7091

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-0367	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-0367	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
50090-3541	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
50090-3541	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
50090-3541	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	A-S Medication Solutions	ANDA	Current
51662-1343	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1343	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1343	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1343	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
53225-3660	ReadySharp Dexamethasone	Dexamethasone Sodium Phosphate	Terrain Pharmaceuticals	ANDA	Current
53225-3660	ReadySharp Dexamethasone	Dexamethasone Sodium Phosphate	Terrain Pharmaceuticals	ANDA	Current
53225-3660	ReadySharp Dexamethasone	Dexamethasone Sodium Phosphate	Terrain Pharmaceuticals	ANDA	Current
53225-3660	ReadySharp Dexamethasone	Dexamethasone Sodium Phosphate	Terrain Pharmaceuticals	ANDA	Current
55154-5118	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Cardinal Health	ANDA	Current
55154-5118	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Cardinal Health	ANDA	Current
55154-5118	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Cardinal Health 107, LLC	ANDA	Current
68788-7441	ReadySharp Dexamethasone	Dexamethasone Sodium Phosphate	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-0532	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0532	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70518-0532	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
70529-045	Viadox	Dexamethasone Sodium Phosphate	IT3 Medical LLC	ANDA	Current
70529-045	Viadox	Dexamethasone Sodium Phosphate	IT3 Medical LLC	ANDA	Current
70529-045	Viadox	Dexamethasone Sodium Phosphate	IT3 Medical LLC	ANDA	Current
71872-7091	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7091	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
72572-122	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Civica, Inc.	ANDA	Current