Application 215604

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	1.5MG	No	No
002	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	4MG	No	No
003	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	6MG	No	No
004	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	0.5MG	No	No
005	DEXAMETHASONE	DEXAMETHASONE	TABLET;ORAL	0.75MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A215604-001	DEXAMETHASONE	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08
A215604-002	DEXAMETHASONE	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08
A215604-003	DEXAMETHASONE	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08
A215604-004	DEXAMETHASONE	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05
A215604-005	DEXAMETHASONE	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A215604-001	AB
A215604-002	AB
A215604-003	AB
A215604-004	AB
A215604-005	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 3 · 117 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	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-001	DEXAMETHASONE	1.5MG	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-002	DEXAMETHASONE	4MG	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-003	DEXAMETHASONE	6MG	TABLET / ORAL	AB	2022-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-004	DEXAMETHASONE	0.5MG	TABLET / ORAL	AB	2023-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-005	DEXAMETHASONE	0.75MG	TABLET / ORAL	AB	2023-10-05	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 117 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	A215604-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215604-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215604-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215604-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215604-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215604-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215604-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215604-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215604-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215604-005	AB	1	`5bbf6a4d5a75…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dexamethasone	DEXAMETHASONE	Preferred Pharmaceuticals, Inc.	c4d1e578-a1d2-4d5e-8426-6b2c39f0d9bd	2026-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	REMEDYREPACK INC.	8c5375a7-7a0d-4af0-8b86-bc87698ac3d1	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	141e16a7-1f3d-3943-e063-6294a90ac5a9	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	Direct_Rx	fade983c-81fb-df94-e053-6394a90a7560	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	Direct_Rx	044d7898-4ab6-a0b3-e063-6294a90acdba	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	American Health Packaging	23deb5f1-d357-45af-9851-d1249bdfa6dd	2024-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604 ndc (product): 60687-718
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	710ce0fc-78b3-402d-a2ca-e5eda09f3211	2024-06-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	Bryant Ranch Prepack	c75360d3-2e4f-4620-a8f0-db28b1aa704b	2024-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	NuCare Pharmaceuticals,Inc.	17f56402-331e-2e3d-e063-6394a90acc0e	2024-05-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	NorthStar Rx LLC	05c77a4c-c508-babd-e063-6294a90a450a	2024-03-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604
Dexamethasone	DEXAMETHASONE	ANI Pharmaceuticals, Inc.	fe8cf911-84ef-47be-acb8-0501b546299b	2024-03-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215604 application number: ANDA215604 ndc (product): 70954-401 ndc (product): 70954-404 ndc (product): 70954-403

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
60687-718	Dexamethasone	Dexamethasone	American Health Packaging	ANDA	Current
70954-401	Dexamethasone	Dexamethasone	Novitium Pharma LLC	ANDA	Current
70954-403	Dexamethasone	Dexamethasone	Novitium Pharma LLC	ANDA	Current
70954-404	Dexamethasone	Dexamethasone	Novitium Pharma LLC	ANDA	Current