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Generated: September 22, 2017

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 sixty-eight drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.

Summary for NDA: 022581

Tradename:
1
Applicant:
1
Ingredient:
1
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 49230-643-31 1 BOTTLE in 1 CARTON (49230-643-31) > 473 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength667MG/5ML
Approval Date:Apr 18, 2011TE:RLD:Yes
Patent:► SubscribePatent Expiration:Feb 23, 2030Product Flag?YSubstance Flag?Delist Request?
Patented Use:USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
Patent:► SubscribePatent Expiration:Jul 20, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
Patent:► SubscribePatent 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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