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Generated: February 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022581

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NDA 022581 describes PHOSLYRA, which is a drug marketed by Fresenius Medcl and is included in one NDA. It is available from one supplier. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PHOSLYRA profile page.

The generic ingredient in PHOSLYRA is calcium acetate. There are two hundred and seventy-two drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
Summary for 022581
Tradename:PHOSLYRA
Applicant:Fresenius Medcl
Ingredient:calcium acetate
Patents:3
Therapeutic Class:Genitourinary Agents
Therapeutic Nutrients/Minerals/Electrolytes
Formulation / Manufacturing:see details
Pharmacology for NDA: 022581
Suppliers and Packaging for NDA: 022581
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PHOSLYRA calcium acetate SOLUTION;ORAL 022581 NDA Fresenius Medical Care North America 49230-643 N 49230-643-31

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength667MG/5ML
Approval Date:Apr 18, 2011TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
Patent:➤ Try a Free TrialPatent Expiration:Jul 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
Patent:➤ Try a Free TrialPatent Expiration:Jul 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS

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