Application 215279

Type: ANDA
Sponsor: NOVITIUM PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	TABLET;ORAL	0.1MG	No	No

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

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
A215279-001	FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB		2022-05-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215279-001	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.

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	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215279-001	FLUDROCORTISONE ACETATE	0.1MG	TABLET / ORAL	AB	2022-05-31	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215279-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215279-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215279-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215279-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215279-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215279-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215279-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215279-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215279-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215279-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215279-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215279-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215279-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215279-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215279-001	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215279-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215279-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215279-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215279-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215279-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215279-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215279-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215279-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215279-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215279-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215279-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215279-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215279-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215279-001	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Major Pharmaceuticals	933e28ef-05e8-419e-a786-21eab67f33a2	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7	2026-05-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	3d6f1a89-ea11-474d-aaca-64fea02a3beb	2024-07-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NorthStar Rx LLC	04ad6ba3-6781-b5df-e063-6294a90a7e6e	2023-09-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Novitium Pharma LLC	96dbbf53-962b-49a4-a60d-91ae0b9fb9ff	2022-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215279 application number: ANDA215279 ndc (product): 70954-252

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70954-252	Fludrocortisone Acetate	Fludrocortisone Acetate	Novitium Pharma LLC	ANDA	Current