Last Updated: September 24, 2026

Details for New Drug Application (NDA): 021160

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NDA 021160 describes PHOSLO GELCAPS, which is a drug marketed by Fresenius Medcl Care and is included in one NDA. Additional details are available on the PHOSLO GELCAPS profile page.

The generic ingredient in PHOSLO GELCAPS is calcium acetate. There is one drug master file entry for this compound. Twenty suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

Summary for 021160

Tradename:	PHOSLO GELCAPS
Applicant:	Fresenius Medcl Care
Ingredient:	calcium acetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	333.5MG
Approval Date:	Apr 2, 2001	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	667MG
Approval Date:	Apr 2, 2001	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	667MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Apr 2, 2001	TE:		RLD:	Yes

Expired US Patents for NDA 021160

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Medcl Care	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-001	Apr 2, 2001	⤷ Start Trial	⤷ Start Trial
Fresenius Medcl Care	PHOSLO GELCAPS	calcium acetate	CAPSULE;ORAL	021160-003	Apr 2, 2001	⤷ Start Trial	⤷ Start Trial
Fresenius Medcl Care	PHOSLO	calcium acetate	CAPSULE;ORAL	021160-002	Apr 2, 2001	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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