Details for New Drug Application (NDA): 213484
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The generic ingredient in LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE 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 213484
Tradename: | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE |
Applicant: | Bionpharma |
Ingredient: | loperamide hydrochloride; simethicone |
Patents: | 0 |
Pharmacology for NDA: 213484
Mechanism of Action | Opioid Agonists |
Physiological Effect | Skin Barrier Activity |
Suppliers and Packaging for NDA: 213484
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 213484 | ANDA | Bionpharma Inc. | 69452-210 | 69452-210-04 | 1 BLISTER PACK in 1 CARTON (69452-210-04) / 6 TABLET in 1 BLISTER PACK |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 213484 | ANDA | Bionpharma Inc. | 69452-210 | 69452-210-12 | 4 BLISTER PACK in 1 CARTON (69452-210-12) / 6 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG;125MG | ||||
Approval Date: | Sep 10, 2021 | TE: | RLD: | No |
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