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Last Updated: September 29, 2020

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Details for New Drug Application (NDA): 073243

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NDA 073243 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Bionpharma Inc, Mylan, Roxane, Teva, Yaopharma Co Ltd, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma Ltd, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, and Sun Pharm Inds Ltd, and is included in twenty-five NDAs. It is available from one hundred and five 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. Nineteen suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 073243
Tradename:LOPERAMIDE HYDROCHLORIDE
Applicant:Perrigo
Ingredient:loperamide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 073243

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Jan 21, 1992TE:RLD:No

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