Application 084282

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 4MG PHOSPHATE/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A084282-001	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A084282-001	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 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A084282-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A084282-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A084282-001	DEXAMETHASONE SODIUM PHOSPHATE	EQ 4MG PHOSPHATE/ML	INJECTABLE / INJECTION	AP	Approved before 1982	`a50c72e98297…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A084282-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A084282-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A084282-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A084282-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A084282-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A084282-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A084282-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A084282-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A084282-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A084282-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A084282-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A084282-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A084282-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A084282-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A084282-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A084282-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A084282-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A084282-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A084282-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A084282-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A084282-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A084282-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A084282-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A084282-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A084282-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A084282-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A084282-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A084282-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A084282-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A084282-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A084282-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A084282-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A084282-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A084282-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A084282-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A084282-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A084282-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A084282-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A084282-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A084282-001	AP	1	`f41ea6bd6efb…`

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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	ASCLEMED USA INC.	a31b013f-924c-42f8-b8ab-ce60bb8ad7b8	2026-08-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	REMEDYREPACK INC.	1596a3b4-8c2c-41b4-b1eb-af09863eaa13	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282
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): 084282 application number: ANDA084282 ndc (product): 0641-6146 ndc (product): 0641-6145
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Henry Schein, Inc.	d9b935d5-1b4f-4a08-8d40-57f397368fef	2025-09-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Civica, Inc.	d54a27f2-2af8-4f86-a7fd-453f6b1a9997	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282 ndc (product): 72572-120
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	18a70010-6cc5-19e2-e063-6394a90a0ea6	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282
DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	8e36534f-d64c-7e7b-e053-2995a90ad48e	2024-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282 ndc (product): 51662-1297
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	8effed8e-9a75-eb3e-e053-2a95a90a965b	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282 ndc (product): 71872-7171
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Medical Purchasing Solutions, LLC	8969803e-2e45-1f28-e053-2995a90a05a7	2023-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282 ndc (product): 71872-7164
Dexamethasone Sodium Phosphate	DEXAMETHASONE SODIUM PHOSPHATE	Asclemed USA, Inc.	2d96d5e8-00bf-406b-b345-f1c31865fe94	2023-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 084282 application number: ANDA084282

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0641-6145	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6145	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0641-6146	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	West-Ward Pharmaceuticals Corp.	ANDA	Current
0641-6146	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
51662-1297	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1297	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1297	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
51662-1297	DEXAMETHASONE SODIUM PHOSPHATE	DEXAMETHASONE SODIUM PHOSPHATE	HF Acquisition Co LLC, DBA HealthFirst	ANDA	Current
70518-3458	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	REMEDYREPACK INC.	ANDA	Current
71872-7164	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
71872-7171	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Medical Purchasing Solutions, LLC	ANDA	Current
72572-120	Dexamethasone Sodium Phosphate	Dexamethasone Sodium Phosphate	Civica, Inc.	ANDA	Current