Details for New Drug Application (NDA): 017690
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NDA 017690 describes IMODIUM, which is a drug marketed by J And J Consumer Inc, Janssen Pharms, and Kenvue Brands, and is included in eight NDAs. Additional details are available on the IMODIUM profile page.
The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
The generic ingredient in IMODIUM is loperamide hydrochloride; simethicone. There are eleven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride; simethicone profile page.
Summary for 017690
| Tradename: | IMODIUM |
| Applicant: | J And J Consumer Inc |
| Ingredient: | loperamide hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 017690
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | CAPSULE;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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