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Last Updated: October 18, 2021

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Details for New Drug Application (NDA): 010060

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NDA 010060 describes FLORINEF, which is a drug marketed by Casper Pharma Llc and is included in one NDA. Additional details are available on the FLORINEF profile page.

The generic ingredient in FLORINEF is fludrocortisone acetate. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fludrocortisone acetate profile page.
Summary for 010060
Applicant:Casper Pharma Llc
Ingredient:fludrocortisone acetate
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 010060

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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