Details for New Drug Application (NDA): 209837
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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 209837
Tradename: | LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE |
Applicant: | Perrigo R And D |
Ingredient: | loperamide hydrochloride; simethicone |
Patents: | 0 |
Pharmacology for NDA: 209837
Mechanism of Action | Opioid Agonists |
Physiological Effect | Skin Barrier Activity |
Suppliers and Packaging for NDA: 209837
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 209837 | ANDA | L. Perrigo Company | 0113-0087 | 0113-0087-53 | 12 BLISTER PACK in 1 CARTON (0113-0087-53) / 1 TABLET in 1 BLISTER PACK |
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE | loperamide hydrochloride; simethicone | TABLET;ORAL | 209837 | ANDA | L. Perrigo Company | 0113-0087 | 0113-0087-62 | 24 BLISTER PACK in 1 CARTON (0113-0087-62) / 1 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG;125MG | ||||
Approval Date: | Sep 5, 2018 | TE: | RLD: | No |
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