Application 088481

Type: ANDA
Sponsor: FERA PHARMS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	6MG	No	No
002	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	0.5MG	No	No
003	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	0.75MG	No	No
004	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	4MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A088481-001	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28
A088481-002	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28
A088481-003	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28
A088481-004	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A088481-001	AB
A088481-002	BP
A088481-003	BP
A088481-004	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 1 of 5 · 164 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
2026-02-19 14:30 UTC	2026-02	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088481-001	DEXAMETHASONE	6MG	TABLET / ORAL	AB	1983-11-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-002	DEXAMETHASONE	0.5MG	TABLET / ORAL	BP	1983-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-003	DEXAMETHASONE	0.75MG	TABLET / ORAL	BP	1983-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-004	DEXAMETHASONE	4MG	TABLET / ORAL	AB	1983-04-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 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	A088481-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-002	BP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-003	BP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A088481-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-002	BP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-003	BP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A088481-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A088481-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-002	BP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-003	BP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A088481-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-002	BP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-003	BP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A088481-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-002	BP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-003	BP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A088481-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-002	BP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-003	BP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A088481-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-002	BP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-003	BP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A088481-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-002	BP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-003	BP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A088481-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-002	BP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-003	BP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A088481-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A088481-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-002	BP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-003	BP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A088481-004	AB	1	`d06236e962d9…`

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	Redpharm Drug, Inc.	115e1bfb-1697-d567-e063-6394a90a78e5	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481
Dexamethasone	DEXAMETHASONE	Advanced Rx Pharmacy of Tennessee, LLC	fa16db27-3c8c-eb22-e053-6394a90add59	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	36f104ba-80b4-4713-aa74-f80483b7bded	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481 ndc (product): 71335-2108
Dexamethasone	DEXAMETHASONE	Alvogen Inc.	9ab26af9-8196-e3d3-76a3-75227fd4e1c3	2024-02-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481 ndc (product): 47781-916 ndc (product): 47781-914
Dexamethasone	DEXAMETHASONE	Proficient Rx LP	6f917c55-034a-40c5-9011-0e10e94d0eba	2022-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 088481 application number: ANDA088481 ndc (product): 71205-703

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 33 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-155	Dexamethasone	dexamethasone	AvKARE	ANDA	Current
47781-914	Dexamethasone	dexamethasone	Alvogen Inc.	ANDA	Current
47781-914	Dexamethasone	dexamethasone	Alvogen Inc.	ANDA	Current
47781-916	Dexamethasone	dexamethasone	Alvogen Inc.	ANDA	Current
47781-916	Dexamethasone	dexamethasone	Alvogen Inc.	ANDA	Current
48102-045	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-045	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-046	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-046	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-047	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-047	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-047	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-048	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-048	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-049	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-050	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-051	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-051	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
48102-052	Dexamethasone	dexamethasone	Fera Pharmaceuticals, LLC	ANDA	Current
49884-373	Dexamethasone	dexamethasone	Par Pharmaceutical Inc.	ANDA	Current
49884-373	Dexamethasone	dexamethasone	Par Pharmaceutical Inc.	ANDA	Current
55700-961	Dexamethasone	dexamethasone	Quality Care Products, LLC	ANDA	Current
55700-961	Dexamethasone	dexamethasone	Quality Care Products, LLC	ANDA	Current
58463-014	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-014	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-015	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-015	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-016	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-016	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-017	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
58463-017	Decadron	dexamethasone	Pragma Pharmaceuticals, LLC	ANDA	Current
71205-703	Dexamethasone	dexamethasone	Proficient Rx LP	ANDA	Current
71335-2108	Dexamethasone	dexamethasone	Bryant Ranch Prepack	ANDA	Current