Details for New Drug Application (NDA): 217471
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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 217471
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Zydus Lifesciences |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 217471
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 217471
Suppliers and Packaging for NDA: 217471
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 217471 | ANDA | Zydus Lifesciences Limited | 70771-1769 | 70771-1769-1 | 100 CAPSULE in 1 BOTTLE (70771-1769-1) |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | CAPSULE;ORAL | 217471 | ANDA | Zydus Lifesciences Limited | 70771-1769 | 70771-1769-4 | 10 BLISTER PACK in 1 CARTON (70771-1769-4) / 10 CAPSULE in 1 BLISTER PACK (70771-1769-2) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CAPSULE;ORAL | Strength | 2MG | ||||
Approval Date: | Mar 23, 2023 | TE: | AB | RLD: | No |
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