Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries
➤ Start Trial

or, See Plans & Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Daiichi Sankyo
Harvard Business School
Fish and Richardson
Johnson and Johnson

Generated: March 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206548

« Back to Dashboard

NDA 206548 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 206548
Applicant:Aurobindo Pharma Ltd
Ingredient:loperamide hydrochloride
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 206548
Suppliers and Packaging for NDA: 206548
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 206548 ANDA Aurohealth LLC 58602-701 N 58602-701-45
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 206548 ANDA Aurohealth LLC 58602-701 N 58602-701-52

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength2MG
Approval Date:Dec 15, 2015TE:RLD:No

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
Johnson and Johnson
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.