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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 207179


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NDA 207179 describes SEVELAMER CARBONATE, which is a drug marketed by Aurobindo Pharma, Bionpharma, Chartwell Rx, Dr Reddys, Impax, Lupin Ltd, Strides Pharma, Amneal Pharms Co, Anxin, Arthur Grp, Impax Labs Inc, Invagen Pharms, Macleods Pharms Ltd, Micro Labs, Rising, and Zydus Pharms, and is included in twenty NDAs. It is available from twenty-six suppliers. Additional details are available on the SEVELAMER CARBONATE profile page.

The generic ingredient in SEVELAMER CARBONATE is sevelamer carbonate. There are thirty-two drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the sevelamer carbonate profile page.
Summary for 207179
Tradename:SEVELAMER CARBONATE
Applicant:Aurobindo Pharma
Ingredient:sevelamer carbonate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207179
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 207179
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207179 ANDA NCS HealthCare of KY, Inc dba Vangard Labs 0615-8239 0615-8239-39 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8239-39)
SEVELAMER CARBONATE sevelamer carbonate TABLET;ORAL 207179 ANDA NorthStar Rx LLC 16714-814 16714-814-01 270 TABLET, FILM COATED in 1 BOTTLE (16714-814-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Jul 17, 2017TE:ABRLD:No

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