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Details for New Drug Application (NDA): 205739

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NDA 205739 describes VELTASSA, which is a drug marketed by Relypsa Inc and is included in one NDA. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the VELTASSA profile page.

The generic ingredient in VELTASSA is patiromer sorbitex calcium. One supplier is listed for this compound. Additional details are available on the patiromer sorbitex calcium profile page.

Summary for NDA: 205739

Tradename:
VELTASSA
Applicant:
Relypsa Inc
Ingredient:
patiromer sorbitex calcium
Patents:9

Pharmacology for NDA: 205739

Suppliers and Packaging for NDA: 205739

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VELTASSA
patiromer sorbitex calcium
POWDER;ORAL 205739 NDA Relypsa, Inc. 53436-084 53436-084-92 4 PACKET in 1 CARTON (53436-084-92) > 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-91)
VELTASSA
patiromer sorbitex calcium
POWDER;ORAL 205739 NDA Relypsa, Inc. 53436-084 53436-084-04 4 PACKET in 1 CARTON (53436-084-04) > 1 POWDER, FOR SUSPENSION in 1 PACKET (53436-084-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:POWDER;ORALStrengthEQ 8.4GM BASE/PACKET
Approval Date:Oct 21, 2015TE:RLD:No
Patent:8,147,873Patent Expiration:Mar 11, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:8,282,913Patent Expiration:Mar 11, 2026Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Oct 21, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY


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