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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 074091


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NDA 074091 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 four 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 074091
Tradename:LOPERAMIDE HYDROCHLORIDE
Applicant:Ohm Labs
Ingredient:loperamide hydrochloride
Patents:0
Pharmacology for NDA: 074091
Mechanism of ActionOpioid Agonists
Medical Subject Heading (MeSH) Categories for 074091
Suppliers and Packaging for NDA: 074091
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 074091 ANDA Lil' Drug Store Products, Inc. 29485-9286 29485-9286-2 25 POUCH in 1 BOX (29485-9286-2) / 1 TABLET in 1 POUCH
LOPERAMIDE HYDROCHLORIDE loperamide hydrochloride TABLET;ORAL 074091 ANDA Lil' Drug Store Products, Inc. 29485-9286 29485-9286-3 30 POUCH in 1 BOX (29485-9286-3) / 1 TABLET in 1 POUCH

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength2MG
Approval Date:Dec 10, 1992TE:RLD:No

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