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Last Updated: November 28, 2020

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Details for New Drug Application (NDA): 204724

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NDA 204724 describes SEVELAMER HYDROCHLORIDE, which is a drug marketed by Glenmark Pharms Ltd and is included in one NDA. It is available from two suppliers. Additional details are available on the SEVELAMER HYDROCHLORIDE profile page.

The generic ingredient in SEVELAMER HYDROCHLORIDE is sevelamer hydrochloride. There are thirty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the sevelamer hydrochloride profile page.
Summary for 204724
Applicant:Glenmark Pharms Ltd
Ingredient:sevelamer hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 204724
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 204724
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SEVELAMER HYDROCHLORIDE sevelamer hydrochloride TABLET;ORAL 204724 ANDA American Health Packaging 60687-449 60687-449-01 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-449-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-449-11)
SEVELAMER HYDROCHLORIDE sevelamer hydrochloride TABLET;ORAL 204724 ANDA Glenmark Pharmaceuticals Inc., USA 68462-446 68462-446-26 360 TABLET, FILM COATED in 1 BOTTLE (68462-446-26)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Feb 8, 2019TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Feb 8, 2019TE:ABRLD:No

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