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Last Updated: October 13, 2024

Details for New Drug Application (NDA): 218122


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NDA 218122 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in thirty-seven NDAs. It is available from one hundred and four suppliers. Additional details are available on the LOPERAMIDE HYDROCHLORIDE profile page.

The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 218122
Pharmacology for NDA: 218122
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 218122
Suppliers and Packaging for NDA: 218122
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 218122 ANDA Aurobindo Pharma Limited 59651-691 59651-691-01 100 CAPSULE in 1 BOTTLE (59651-691-01)
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 218122 ANDA Aurobindo Pharma Limited 59651-691 59651-691-05 500 CAPSULE in 1 BOTTLE (59651-691-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength2MG
Approval Date:Sep 5, 2023TE:ABRLD:No

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