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BioPharmaceutical Business Intelligence

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

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Serving leading biopharmaceutical companies globally:

US Army
Medtronic
Deloitte
Harvard Business School
Chinese Patent Office
Mallinckrodt
US Department of Justice
Cantor Fitzgerald
Fuji
Cipla

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076497

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NDA 076497 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 nineteen 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 076497

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Gastrointestinal Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 076497

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 076497 ANDA Walgreen Company 0363-0375 0363-0375-46 1 BOTTLE, PLASTIC in 1 CARTON (0363-0375-46) > 96 TABLET in 1 BOTTLE, PLASTIC
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 076497 ANDA Walgreen Company 0363-0375 0363-0375-90 5 BLISTER PACK in 1 CARTON (0363-0375-90) > 6 TABLET in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength2MG
Approval Date:Jun 10, 2003TE:RLD:No


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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Cerilliant
US Army
Chubb
Moodys
Teva
McKesson
Harvard Business School
Queensland Health
Citi

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.

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