Details for New Drug Application (NDA): 021160

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

The generic ingredient in PHOSLO GELCAPS is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-two 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
Ingredient:	calcium acetate
Patents:	0

Suppliers and Packaging for NDA: 021160

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PHOSLO	calcium acetate	CAPSULE;ORAL	021160	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-2081	0781-2081-02	200 CAPSULE in 1 BOTTLE (0781-2081-02)
PHOSLO	calcium acetate	CAPSULE;ORAL	021160	NDA AUTHORIZED GENERIC	Sandoz Inc	0781-2672	0781-2672-02	200 CAPSULE in 1 BOTTLE (0781-2672-02)

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

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