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, Chartwell Rx, Hikma Pharms, Impax Labs, and Novitium Pharma, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for fludrocortisone acetate

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	6
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	10
Patent Applications:	6,210
Drug Prices:	Drug price trends for fludrocortisone acetate
What excipients (inactive ingredients) are in fludrocortisone acetate?	fludrocortisone acetate excipients list
DailyMed Link:	fludrocortisone acetate at DailyMed

See drug prices for fludrocortisone acetate

Recent Clinical Trials for fludrocortisone acetate

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	Phase 3
Merck Sharp & Dohme LLC	Phase 1

See all fludrocortisone acetate clinical trials

Medical Subject Heading (MeSH) Categories for fludrocortisone acetate

Anti-Inflammatory Agents

Anatomical Therapeutic Chemical (ATC) Classes for fludrocortisone acetate

US Patents and Regulatory Information for fludrocortisone acetate

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma Pharms	FLUDROCORTISONE ACETATE	fludrocortisone acetate	TABLET;ORAL	091302-001	Jul 22, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	FLUDROCORTISONE ACETATE	fludrocortisone acetate	TABLET;ORAL	215279-001	May 31, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Barr	FLUDROCORTISONE ACETATE	fludrocortisone acetate	TABLET;ORAL	040425-001	Jan 21, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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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