Details for New Drug Application (NDA): 091292
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The generic ingredient in LOPERAMIDE HYDROCHLORIDE is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 091292
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Perrigo R And D |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 091292
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 091292
Suppliers and Packaging for NDA: 091292
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | SUSPENSION;ORAL | 091292 | ANDA | L. Perrigo Company | 0113-1645 | 0113-1645-26 | 120 mL in 1 BOTTLE (0113-1645-26) |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | SUSPENSION;ORAL | 091292 | ANDA | Walgreen Company | 0363-0645 | 0363-0645-26 | 120 mL in 1 BOTTLE (0363-0645-26) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 1MG/7.5ML | ||||
Approval Date: | May 20, 2011 | TE: | RLD: | No |
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