Details for New Drug Application (NDA): 019487
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The generic ingredient in IMODIUM A-D is loperamide hydrochloride. There are eleven drug master file entries for this compound. Ninety-nine suppliers are listed for this compound. Additional details are available on the loperamide hydrochloride profile page.
Summary for 019487
Tradename: | IMODIUM A-D |
Applicant: | J And J Consumer Inc |
Ingredient: | loperamide hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 019487
Mechanism of Action | Opioid Agonists |
Medical Subject Heading (MeSH) Categories for 019487
Suppliers and Packaging for NDA: 019487
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487 | NDA | Johnson & Johnson Consumer Inc. | 50580-134 | 50580-134-04 | 120 mL in 1 BOTTLE (50580-134-04) |
IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487 | NDA | Johnson & Johnson Consumer Inc. | 50580-134 | 50580-134-08 | 240 mL in 1 BOTTLE (50580-134-08) |
Profile for product number 001
Active Rx/OTC/Discontinued: | OTC | Dosage: | SOLUTION;ORAL | Strength | 1MG/5ML | ||||
Approval Date: | Mar 1, 1988 | TE: | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | OTC | Dosage: | SUSPENSION;ORAL | Strength | 1MG/7.5ML | ||||
Approval Date: | Jul 8, 2004 | TE: | RLD: | Yes |
Expired US Patents for NDA 019487
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
J And J Consumer Inc | IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487-001 | Mar 1, 1988 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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