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Generated: December 12, 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 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 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:

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