Application 040700

Type: ANDA
Sponsor: ECR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	1.5MG	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
A040700-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL			2008-08-15

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 · 43 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
2026-09-14 22:38:34	2026-08	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2008-08-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A040700-001	DEXAMETHASONE	1.5MG	TABLET / ORAL		2008-08-15	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040700-001	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040700-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040700-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040700-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040700-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040700-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040700-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040700-001	AB	1	`ea99ee380514…`

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 5 of 5 · 86 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Doc Rx	f1c30431-554b-4161-9d8c-5795c689e0bd	2021-06-11	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	35307d74-aed8-4c6b-9568-2223a4f350bd	2021-01-01	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	a9fd2013-0797-4ec4-82c5-07d282522625	2020-09-17	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
TaperDex 6-day	DEXAMETHASONE	Proficient Rx LP	a0d298f3-6ba6-45a5-81bf-82a3ad93d0a9	2020-03-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	89e570c9-3e64-433b-9779-b94332f2b5ef	2020-02-25	Warnings, Adverse reactions	Name fallback brand name: Dexamethasone generic name: DEXAMETHASONE
TaperDex 12-day	DEXAMETHASONE	Proficient Rx LP	d66e36d3-f6f8-4fa8-84fb-7717463e37b3	2019-10-01	Warnings, Adverse reactions	Name fallback generic name: DEXAMETHASONE

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
0095-0087	Dexamethasone	Dexamethasone	Bausch Health US LLC	ANDA	Current
0095-0087	Dexamethasone	Dexamethasone	ECR Pharmaceuticals	ANDA	Current
0095-0087	Dexamethasone	Dexamethasone	Bausch Health US LLC	ANDA	Current
0095-0087	Dexamethasone	Dexamethasone	Bausch Health Americas, Inc.	ANDA	Current
0095-0088	Dexamethasone	Dexamethasone	Bausch Health US LLC	ANDA	Current
0095-0088	Dexamethasone	Dexamethasone	ECR Pharmaceuticals	ANDA	Current
0095-0088	Dexamethasone	Dexamethasone	Bausch Health US LLC	ANDA	Current
0095-0088	Dexamethasone	Dexamethasone	Bausch Health Americas, Inc.	ANDA	Current
0095-0089	Dexamethasone	Dexamethasone	Bausch Health US LLC	ANDA	Current
0095-0089	Dexamethasone	Dexamethasone	ECR Pharmaceuticals	ANDA	Current
0095-0089	Dexamethasone	Dexamethasone	Bausch Health US LLC	ANDA	Current
0095-0089	Dexamethasone	Dexamethasone	Bausch Health Americas, Inc.	ANDA	Current