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Last Updated: July 7, 2020

DrugPatentWatch Database Preview

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 three suppliers. There are two patents protecting this drug. 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-eight 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021160
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)
Paragraph IV (Patent) Challenges for 021160
Tradename Dosage Ingredient NDA Submissiondate
PHOSLO CAPSULE;ORAL calcium acetate 021160 2005-05-31
PHOSLO GELCAPS CAPSULE;ORAL calcium acetate 021160 2005-05-31

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength333.5MG
Approval Date:Apr 2, 2001TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength667MG
Approval Date:Apr 2, 2001TE:RLD:No
Patent:  Start TrialPatent Expiration:Apr 3, 2021Product Flag?Substance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength667MG
Approval Date:Apr 2, 2001TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Apr 3, 2021Product Flag?Substance Flag?Delist Request?

Expired US Patents for NDA 021160

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