Last Updated: November 13, 2026

Details for New Drug Application (NDA): 022067

NDA 022067 describes FLO-PRED, which is a drug marketed by Sun Pharma Canada and is included in one NDA. There is one patent protecting this drug. Additional details are available on the FLO-PRED profile page.

The generic ingredient in FLO-PRED is prednisolone acetate. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the prednisolone acetate profile page.

Summary for 022067

Tradename:	FLO-PRED
Applicant:	Sun Pharma Canada
Ingredient:	prednisolone acetate
Patents:	1

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 5MG BASE/5ML
Approval Date:	Jan 17, 2008	TE:		RLD:	No
Patent:	7,799,331	Patent Expiration:	Oct 11, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ALLERGIC REACTIONS
Patent:	7,799,331	Patent Expiration:	Oct 11, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ASTHMA

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUSPENSION;ORAL			Strength	EQ 15MG BASE/5ML
Approval Date:	Jan 17, 2008	TE:		RLD:	No
Patent:	7,799,331	Patent Expiration:	Oct 11, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ALLERGIC REACTIONS

Expired US Patents for NDA 022067

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	5,881,926	⤷ Start Trial
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	6,399,079	⤷ Start Trial
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,071,523	⤷ Start Trial
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,399,079	⤷ Start Trial
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,656,482	⤷ Start Trial
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	6,102,254	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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