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Details for New Drug Application (NDA): 073243

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NDA 073243 describes LOPERAMIDE HYDROCHLORIDE, which is a drug marketed by Teva, Able, Wockhardt, Perrigo, Mylan, Aurobindo Pharma Ltd, Hi Tech Pharma, Contract Pharmacal, Bionpharma Inc, Watson Labs, 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 fourteen 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: 073243

loperamide hydrochloride
Therapeutic Class:Gastrointestinal Agents

Suppliers and Packaging for NDA: 073243

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
loperamide hydrochloride
SOLUTION;ORAL 073243 ANDA L. Perrigo Company 0113-0377 0113-0377-26 1 BOTTLE in 1 CARTON (0113-0377-26) > 120 mL in 1 BOTTLE
loperamide hydrochloride
SOLUTION;ORAL 073243 ANDA Target Corporation 11673-377 11673-377-26 1 BOTTLE in 1 CARTON (11673-377-26) > 118 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION;ORALStrength1MG/5ML
Approval Date:Jan 21, 1992TE:RLD:No

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