Details for New Drug Application (NDA): 216876
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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-two suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 216876
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Rubicon |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216876
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 216876
Suppliers and Packaging for NDA: 216876
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 216876 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8497 | 0615-8497-39 | 30 CAPSULE in 1 BLISTER PACK (0615-8497-39) |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 216876 | ANDA | Advagen Pharma Ltd., | 72888-130 | 72888-130-00 | 1000 CAPSULE in 1 BOTTLE (72888-130-00) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Jan 26, 2023 | TE: | AB | RLD: | No |
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