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Serving 500+ biopharmaceutical companies globally:

Cipla
Colorcon
Argus Health
Queensland Health
Citi
Chinese Patent Office
Merck
Boehringer Ingelheim
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Generated: June 25, 2017

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 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 fifteen 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: 074352

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

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 17856-0618-1 10 mL in 1 CUP (17856-0618-1)
LOPERAMIDE HYDROCHLORIDE
loperamide hydrochloride
SOLUTION;ORAL 074352 ANDA Atlantic Biologicals Corps 17856-0618 17856-0618-5 5 mL in 1 CUP (17856-0618-5)

Summary for product number 001

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


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Serving 500+ biopharmaceutical companies globally:

US Army
US Department of Justice
Dow
Teva
Citi
Healthtrust
Baxter
Moodys
Novartis
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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