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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 202190


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NDA 202190 describes COLESEVELAM HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Glenmark Pharms Ltd, Impax, Watson Labs Inc, Beijing Tide Pharm, Bionpharma, Chartwell Rx, Dr Reddys, Impax Labs Inc, Invagen Pharms, Inventia, United Res Labs, Zhejiang Jingxin, and Zydus Pharms, and is included in seventeen NDAs. It is available from fourteen suppliers. Additional details are available on the COLESEVELAM HYDROCHLORIDE profile page.

The generic ingredient in COLESEVELAM HYDROCHLORIDE is colesevelam hydrochloride. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the colesevelam hydrochloride profile page.
Summary for 202190
Pharmacology for NDA: 202190
Mechanism of ActionBile-acid Binding Activity
Medical Subject Heading (MeSH) Categories for 202190
Suppliers and Packaging for NDA: 202190
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COLESEVELAM HYDROCHLORIDE colesevelam hydrochloride FOR SUSPENSION;ORAL 202190 ANDA Glenmark Pharmaceuticals Inc.,USA 68462-620 68462-620-30 30 PACKET in 1 BOX (68462-620-30) / 1 POWDER, FOR SUSPENSION in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength1.875GM/PACKET
Approval Date:Jul 16, 2018TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;ORALStrength3.75GM/PACKET
Approval Date:Jul 16, 2018TE:ABRLD:No

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