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Last Updated: October 18, 2021

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Fludrocortisone acetate - Generic Drug Details

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What are the generic sources for fludrocortisone acetate and what is the scope of freedom to operate?

Fludrocortisone acetate is the generic ingredient in two branded drugs marketed by Casper Pharma Llc, Barr, Hikma Pharms, and Impax Labs, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for fludrocortisone acetate. Ten suppliers are listed for this compound.

Drug Prices for fludrocortisone acetate

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Recent Clinical Trials for fludrocortisone acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The George InstitutePhase 2
Children's Hospital Los AngelesPhase 2
University of MichiganPhase 2

See all fludrocortisone acetate clinical trials

Medical Subject Heading (MeSH) Categories for fludrocortisone acetate

US Patents and Regulatory Information for fludrocortisone acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Barr FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 040425-001 Jan 21, 2003 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hikma Pharms FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 091302-001 Jul 22, 2011 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Impax Labs FLUDROCORTISONE ACETATE fludrocortisone acetate TABLET;ORAL 040431-001 Mar 18, 2002 AB RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Casper Pharma Llc FLORINEF fludrocortisone acetate TABLET;ORAL 010060-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Merck
McKinsey
McKesson
Colorcon
Harvard Business School

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