Details for New Drug Application (NDA): 218122
✉ Email this page to a colleague
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 218122
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma Ltd |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 218122
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 218122
Suppliers and Packaging for NDA: 218122
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 218122 | ANDA | A-S Medication Solutions | 50090-7398 | 50090-7398-0 | 15 CAPSULE in 1 BOTTLE (50090-7398-0) |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 218122 | ANDA | A-S Medication Solutions | 50090-7398 | 50090-7398-3 | 12 CAPSULE in 1 BOTTLE (50090-7398-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Sep 5, 2023 | TE: | AB | RLD: | No |
Complete Access Available with Subscription