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. One hundred and four 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 |
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 | Kenvue Brands LLC | 50580-134 | 50580-134-04 | 120 mL in 1 BOTTLE (50580-134-04) |
IMODIUM A-D | loperamide hydrochloride | SOLUTION;ORAL | 019487 | NDA | Kenvue Brands LLC | 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 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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