Details for New Drug Application (NDA): 021855
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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-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 Action | Opioid 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: | OTC | Dosage: | CAPSULE;ORAL | Strength | 1MG | ||||
Approval Date: | Aug 4, 2005 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Aug 4, 2005 | TE: | RLD: | Yes |
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