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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
McKesson
Baxter
Federal Trade Commission
Chubb
US Army
Accenture
Fuji
Julphar

Generated: December 18, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206548

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NDA 206548 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 206548

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

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 58602-701-01 1 BLISTER PACK in 1 CARTON (58602-701-01) > 6 TABLET in 1 BLISTER PACK
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 206548 ANDA Aurohealth LLC 58602-701 58602-701-34 1 BOTTLE in 1 CARTON (58602-701-34) > 200 TABLET in 1 BOTTLE

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Medtronic
Harvard Business School
AstraZeneca
Chinese Patent Office
Daiichi Sankyo
Deloitte
Merck
Cantor Fitzgerald

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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