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Serving leading biopharmaceutical companies globally:

Colorcon
Daiichi Sankyo
Baxter
AstraZeneca
McKinsey
US Army
US Department of Justice
Farmers Insurance
Johnson and Johnson
Fish and Richardson

Generated: October 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021855

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NDA 021855 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Teva, Able, Wockhardt, L Perrigo Co, Mylan, Perrigo, Aurobindo Pharma Ltd, Hi Tech Pharma, Contract Pharmacal, Bionpharma Inc, Watson Labs, Allied Pharma Inc, Roxane, Alpharma Us Pharms, Duramed Pharms Barr, Ohm Labs, Perrigo R And D, Sandoz, LNK, 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 NDA: 021855

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

Suppliers and Packaging for NDA: 021855

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
CAPSULE;ORAL 021855 NDA Walgreens 0363-0520 0363-0520-24 2 BLISTER PACK in 1 CARTON (0363-0520-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
CAPSULE;ORAL 021855 NDA TARGET Corporation 11673-520 11673-520-24 2 BLISTER PACK in 1 BOX (11673-520-24) > 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength1MG
Approval Date:Aug 4, 2005TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength2MG
Approval Date:Aug 4, 2005TE:RLD:Yes


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Serving leading biopharmaceutical companies globally:

Deloitte
McKinsey
Daiichi Sankyo
AstraZeneca
Harvard Business School
QuintilesIMS
Teva
Covington
UBS
Johnson and Johnson

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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