Details for New Drug Application (NDA): 219016
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The generic ingredient in EDURANT PED is rilpivirine hydrochloride. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
Summary for 219016
Tradename: | EDURANT PED |
Applicant: | Janssen Prods |
Ingredient: | rilpivirine hydrochloride |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 219016
Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 219016
Suppliers and Packaging for NDA: 219016
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
EDURANT PED | rilpivirine hydrochloride | TABLET, FOR SUSPENSION;ORAL | 219016 | NDA | Janssen Products, LP | 59676-280 | 59676-280-90 | 9 BLISTER PACK in 1 CARTON (59676-280-90) / 10 TABLET, FOR SUSPENSION in 1 BLISTER PACK (59676-280-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, FOR SUSPENSION;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Mar 15, 2024 | TE: | RLD: | Yes |
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