Application 010060

Type: NDA
Sponsor: CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLORINEF	FLUDROCORTISONE ACETATE	TABLET;ORAL	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N010060-001	FLORINEF	FLUDROCORTISONE ACETATE	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N010060-001	FLORINEF	0.1MG	TABLET / ORAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N010060-001	FLORINEF	0.1MG	TABLET / ORAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N010060-001	FLORINEF	0.1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD, Approved before 1982	`f41ea6bd6efb…`

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 · 16 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	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	89b5687a-6e21-47cd-9c05-d9c9f4f8cf49	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
fludrocortisone acetate	FLUDROCORTISONE ACETATE	Eywa Pharma Inc	eff2eae8-94ce-46ca-a027-6b1d08e7b96b	2026-05-13	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Cardinal Health 107, LLC	3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da7	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NCS HealthCare of KY, LLC dba Vangard Labs	3c007f9a-4cd5-4e74-a633-d55dde1fe903	2026-02-27	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	AvKARE	b8ce5b7e-7aa2-45f8-e053-2995a90a6c65	2026-01-15	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
FLUDROCORTISONE ACETATE	FLUDROCORTISONE ACETATE	AvPAK	2cd3965d-cab9-a97c-db61-7d03ced154f3	2026-01-08	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals of New York LLC	4ed382df-f2d5-46a4-a68b-aba807777093	2025-12-20	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetate	FLUDROCORTISONE ACETATE	Golden State Medical Supply, Inc.	3752ff25-8887-5c88-e063-6294a90a345a	2025-08-29	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	American Health Packaging	001e72ea-2c9e-468c-90cc-6c347234e2a9	2025-05-19	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetate	FLUDROCORTISONE ACETATE	Zydus Lifesciences Limited	6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e	2024-10-29	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Bryant Ranch Prepack	3d6f1a89-ea11-474d-aaca-64fea02a3beb	2024-07-30	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetate	FLUDROCORTISONE ACETATE	Viona Pharmaceuticals Inc	bc92f5c6-3a65-4fab-85b3-fd5b84f917c1	2024-07-13	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Amneal Pharmaceuticals NY LLC	51363453-6d33-4aee-8426-37ac0bf3cc10	2024-02-09	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	NorthStar Rx LLC	04ad6ba3-6781-b5df-e063-6294a90a7e6e	2023-09-07	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE
Fludrocortisone Acetate	FLUDROCORTISONE ACETATE	Novitium Pharma LLC	96dbbf53-962b-49a4-a60d-91ae0b9fb9ff	2022-06-03	Warnings, Adverse reactions	Name fallback generic name: FLUDROCORTISONE ACETATE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
11887	SUPPL	2004-06-30