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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 022067

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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 are eighty-eight drug master file entries 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	⤷ Get Started Free
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-001	Jan 17, 2008	6,656,482	⤷ Get Started Free
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,656,482	⤷ Get Started Free
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,399,079	⤷ Get Started Free
Sun Pharma Canada	FLO-PRED	prednisolone acetate	SUSPENSION;ORAL	022067-002	Jan 17, 2008	6,071,523	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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