Details for New Drug Application (NDA): 206548
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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 206548
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Aurobindo Pharma |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 206548
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 206548
Suppliers and Packaging for NDA: 206548
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 206548 | ANDA | Amerisource Bergen | 46122-738 | 46122-738-53 | 2 BLISTER PACK in 1 CARTON (46122-738-53) / 6 TABLET in 1 BLISTER PACK |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 206548 | ANDA | Amerisource Bergen | 46122-738 | 46122-738-62 | 4 BLISTER PACK in 1 CARTON (46122-738-62) / 6 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Dec 15, 2015 | TE: | RLD: | No |
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