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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021855


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NDA 021855 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Chartwell Rx, Edenbridge Pharms, Jubilant Cadista, Mylan, Roxane, Rubicon, Strides Pharma, Teva, Zydus Lifesciences, Allied, Alpharma Us Pharms, Duramed Pharms Barr, Perrigo, Sciegen Pharms Inc, Watson Labs, Wockhardt Bio Ag, Perrigo R And D, Able, Aurobindo Pharma, Contract Pharmacal, L Perrigo Co, LNK, Ohm Labs, Granules, Guardian Drug, Hetero Labs Ltd V, and Sun Pharm Inds Ltd, and is included in thirty-seven NDAs. It is available from one hundred and three 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. Thirty-one suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 021855
Tradename:LOPERAMIDE HYDROCHLORIDE
Applicant:Bionpharma
Ingredient:loperamide hydrochloride
Patents:0
Pharmacology for NDA: 021855
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 021855
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 0363-1176 0363-1176-08 1 BLISTER PACK in 1 CARTON (0363-1176-08) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride CAPSULE;ORAL 021855 NDA WALGREENS 0363-1176 0363-1176-12 2 BLISTER PACK in 1 CARTON (0363-1176-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

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

Profile for product number 002

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

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