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Serving leading biopharmaceutical companies globally:

McKinsey
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Healthtrust
Argus Health
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Generated: January 24, 2018

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, Sandoz, Teva, Allied Pharma Inc, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt, 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-four NDAs. It is available from one hundred and twenty 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. One supplier is 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
Therapeutic Class:Gastrointestinal Agents
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 Walgreen Company 0363-0645 0363-0645-26 120 mL in 1 BOTTLE (0363-0645-26)

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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Serving leading biopharmaceutical companies globally:

UBS
Baxter
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Colorcon
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Chinese Patent Office
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Cerilliant

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