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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091292

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NDA 091292 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 sixteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 091292
Tradename:LOPERAMIDE HYDROCHLORIDE
Applicant:Perrigo R And D
Ingredient:loperamide hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 091292
Suppliers and Packaging for NDA: 091292
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SUSPENSION;ORAL 091292 ANDA L. Perrigo Company 0113-0645 0113-0645-26 120 mL in 1 BOTTLE (0113-0645-26)
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SUSPENSION;ORAL 091292 ANDA L. Perrigo Company 0113-1645 0113-1645-26 120 mL in 1 BOTTLE (0113-1645-26)

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SUSPENSION;ORALStrength1MG/7.5ML
Approval Date:May 20, 2011TE:RLD:No

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