FDA.reportPublic FDA data

Application 010060

Type
NDA
Sponsor
CASPER PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLORINEFFLUDROCORTISONE ACETATETABLET;ORAL0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010060-001FLORINEFFLUDROCORTISONE ACETATE0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N010060-001FLORINEF0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N010060-001FLORINEF0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010060-001FLORINEF0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010060-001FLORINEF0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD, Approved before 1982a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fludrocortisone AcetateFLUDROCORTISONE ACETATEMajor Pharmaceuticals933e28ef-05e8-419e-a786-21eab67f33a22026-06-24Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATECardinal Health 107, LLC89b5687a-6e21-47cd-9c05-d9c9f4f8cf492026-05-15Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
fludrocortisone acetateFLUDROCORTISONE ACETATEEywa Pharma Inceff2eae8-94ce-46ca-a027-6b1d08e7b96b2026-05-13Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATECardinal Health 107, LLC3e3b8a1f-ed2a-4235-8a8f-e4ffbe9d1da72026-05-06Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATENCS HealthCare of KY, LLC dba Vangard Labs3c007f9a-4cd5-4e74-a633-d55dde1fe9032026-02-27Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAvKAREb8ce5b7e-7aa2-45f8-e053-2995a90a6c652026-01-15Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
FLUDROCORTISONE ACETATEFLUDROCORTISONE ACETATEAvPAK2cd3965d-cab9-a97c-db61-7d03ced154f32026-01-08Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals of New York LLC4ed382df-f2d5-46a4-a68b-aba8077770932025-12-20Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetateFLUDROCORTISONE ACETATEGolden State Medical Supply, Inc.3752ff25-8887-5c88-e063-6294a90a345a2025-08-29Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmerican Health Packaging001e72ea-2c9e-468c-90cc-6c347234e2a92025-05-19Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetateFLUDROCORTISONE ACETATEZydus Lifesciences Limited6c4a7d2d-00a4-4d80-ab4c-2afd4e4f614e2024-10-29Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATEBryant Ranch Prepack3d6f1a89-ea11-474d-aaca-64fea02a3beb2024-07-30Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone acetateFLUDROCORTISONE ACETATEViona Pharmaceuticals Incbc92f5c6-3a65-4fab-85b3-fd5b84f917c12024-07-13Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATEAmneal Pharmaceuticals NY LLC51363453-6d33-4aee-8426-37ac0bf3cc102024-02-09Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATENorthStar Rx LLC04ad6ba3-6781-b5df-e063-6294a90a7e6e2023-09-07Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE
Fludrocortisone AcetateFLUDROCORTISONE ACETATENovitium Pharma LLC96dbbf53-962b-49a4-a60d-91ae0b9fb9ff2022-06-03Warnings, Adverse reactionsName fallback
generic name: FLUDROCORTISONE ACETATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
11887SUPPL2004-06-30