BioPharmaceutical Business Intelligence

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Daiichi Sankyo
Federal Trade Commission
Queensland Health

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074352

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NDA 074352 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Bionpharma Inc, Mylan, Roxane, Teva, Yaopharma Co Ltd, Allied Pharma Inc, 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-four NDAs. It is available from one hundred and eighteen 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 074352
Applicant:Hi Tech Pharma
Ingredient:loperamide hydrochloride
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 074352
Suppliers and Packaging for NDA: 074352
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 074352 ANDA Atlantic Biologicals Corps 17856-0618 N 17856-0618-5
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride SOLUTION;ORAL 074352 ANDA Atlantic Biologicals Corps 17856-0618 N 17856-0618-1

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Nov 17, 1995TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Johnson and Johnson

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