Application 080399

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	0.75MG	No	No
002	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	4MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A080399-001	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982
A080399-002	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A080399-002	AB

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 · 74 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
2021-03-12 10:30 UTC	2021-03	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL			2022-04-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080399-001	DEXAMETHASONE	0.75MG	TABLET / ORAL		Approved before 1982		`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080399-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB		2022-04-20	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A080399-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A080399-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A080399-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A080399-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A080399-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A080399-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A080399-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A080399-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A080399-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A080399-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A080399-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A080399-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A080399-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A080399-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A080399-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A080399-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A080399-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A080399-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A080399-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A080399-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A080399-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A080399-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A080399-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A080399-002	AB	1	`3f0d92c62455…`
2023-01-26 05:58 UTC	2023-01	A080399-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A080399-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A080399-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A080399-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A080399-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A080399-002	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	A-S Medication Solutions	16c59e9a-8e4f-4300-bbbb-bcc982c18fc8	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080399 application number: ANDA080399
Dexamethasone	DEXAMETHASONE	A-S Medication Solutions	89af5591-eebf-44e7-827f-ce3b123123e4	2025-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080399 application number: ANDA080399 ndc (product): 50090-6151
Dexamethasone	DEXAMETHASONE	Prasco Laboratories	bfce6b49-f7ff-4ec7-9580-b730f0a207d7	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 080399 application number: ANDA080399 ndc (product): 66993-730

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6151	Dexamethasone	Dexamethasone	A-S Medication Solutions	ANDA	Current
66993-730	Dexamethasone	Dexamethasone	Prasco Laboratories	ANDA	Current
66993-730	Dexamethasone	Dexamethasone	Prasco Laboratories	ANDA	Current
66993-730	Dexamethasone	Dexamethasone	Prasco Laboratories	ANDA	Current