Details for New Drug Application (NDA): 218122
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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 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 | Aurobindo Pharma Limited | 59651-691 | 59651-691-01 | 100 CAPSULE in 1 BOTTLE (59651-691-01) |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 218122 | ANDA | Aurobindo Pharma Limited | 59651-691 | 59651-691-05 | 500 CAPSULE in 1 BOTTLE (59651-691-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Sep 5, 2023 | TE: | AB | RLD: | No |
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