Application 087916

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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.

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
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP		1982-08-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	AB	RLD, RS	1982-08-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087916-001	DEXAMETHASONE	2MG	TABLET / ORAL	BP	RLD, RS	1982-08-26	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087916-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087916-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087916-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087916-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087916-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087916-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087916-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087916-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087916-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087916-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087916-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087916-001	BP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087916-001	BP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087916-001	BP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087916-001	BP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087916-001	BP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087916-001	BP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087916-001	BP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087916-001	BP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087916-001	BP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087916-001	BP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087916-001	BP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087916-001	BP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087916-001	BP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087916-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087916-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087916-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087916-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087916-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087916-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087916-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087916-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087916-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087916-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087916-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087916-001	BP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087916-001	BP	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Cardinal Health 107, LLC	bf8acfdb-8dc8-4a69-90b0-33c680c421d6	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087916 application number: ANDA087916 ndc (product): 55154-4914
Dexamethasone	DEXAMETHASONE	PD-Rx Pharmaceuticals, Inc.	2ceb3a01-f5bb-4538-b5c1-cea400901d02	2025-10-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087916 application number: ANDA087916 ndc (product): 43063-266
Dexamethasone Intensol	DEXAMETHASONE INTENSOL	Hikma Pharmaceuticals USA, Inc.	b15200fb-1826-472b-a907-e677a272513b	2025-06-06	Warnings, Adverse reactions	Exact identifier ndc (product): 0054-4183 ndc (product): 0054-8176
Dexamethasone	DEXAMETHASONE	Doc Rx	f1c30431-554b-4161-9d8c-5795c689e0bd	2021-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087916 application number: ANDA087916 ndc (product): 69306-112
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	35307d74-aed8-4c6b-9568-2223a4f350bd	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087916 application number: ANDA087916 ndc (product): 63187-383

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
0054-4183	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4183	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4183	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-4183	Dexamethasone	Dexamethasone	Hikma Pharmaceuticals USA, Inc.	ANDA	Current
0054-4183	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-8176	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-8176	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-8176	Dexamethasone	Dexamethasone	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-8176	Dexamethasone	Dexamethasone	Hikma Pharmaceuticals USA, Inc.	ANDA	Current
21695-745	Dexamethasone	Dexamethasone	Rebel Distributors Corp	ANDA	Current
43063-266	Dexamethasone	Dexamethasone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-266	Dexamethasone	Dexamethasone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-266	Dexamethasone	Dexamethasone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-266	Dexamethasone	Dexamethasone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-266	Dexamethasone	Dexamethasone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-266	Dexamethasone	Dexamethasone	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
55154-4914	Dexamethasone	Dexamethasone	Cardinal Health	ANDA	Current
55154-4914	Dexamethasone	Dexamethasone	Cardinal Health 107, LLC	ANDA	Current
55154-4914	Dexamethasone	Dexamethasone	Cardinal Health	ANDA	Current
63187-383	Dexamethasone	Dexamethasone	Proficient Rx LP	ANDA	Current
63187-383	Dexamethasone	Dexamethasone	Proficient Rx LP	ANDA	Current
69306-112	Dexamethasone	Dexamethasone	Doc Rx	ANDA	Current
69306-112	Dexamethasone	Dexamethasone	Doc Rx	ANDA	Current
69306-112	Dexamethasone	Dexamethasone	Doc Rx	ANDA	Current
69306-112	Dexamethasone	Dexamethasone	Doc Rx	ANDA	Current
70518-3050	Dexamethasone	Dexamethasone	REMEDYREPACK INC.	ANDA	Current