Details for New Drug Application (NDA): 022581
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NDA 022581 describes PHOSLYRA, which is a drug marketed by Fresenius Medcl Care and is included in one NDA. 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 eighty-two drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the calcium acetate profile page.
The generic ingredient in PHOSLYRA is calcium acetate. There are two hundred and eighty-two drug master file entries for this compound. Twenty-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 Care |
| Ingredient: | calcium acetate |
| Patents: | 3 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;ORAL | Strength | 667MG/5ML | ||||
| Approval Date: | Apr 18, 2011 | TE: | RLD: | Yes | |||||
| Patent: | 8,591,938 | Patent Expiration: | Feb 23, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS | ||||||||
| Patent: | 8,592,480 | Patent Expiration: | Jul 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS | ||||||||
| Patent: | 9,089,528 | Patent Expiration: | Jul 20, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE OF PHOSLYRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS | ||||||||
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