Details for New Drug Application (NDA): 074091
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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 074091
Tradename: | LOPERAMIDE HYDROCHLORIDE |
Applicant: | Ohm Labs |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 074091
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 074091
Suppliers and Packaging for NDA: 074091
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 074091 | ANDA | Lil' Drug Store Products, Inc. | 29485-9286 | 29485-9286-2 | 25 POUCH in 1 BOX (29485-9286-2) / 1 TABLET in 1 POUCH |
LOPERAMIDE HYDROCHLORIDE | loperamide hydrochloride | TABLET;ORAL | 074091 | ANDA | Lil' Drug Store Products, Inc. | 29485-9286 | 29485-9286-3 | 30 POUCH in 1 BOX (29485-9286-3) / 1 TABLET in 1 POUCH |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Dec 10, 1992 | TE: | RLD: | No |
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