Details for New Drug Application (NDA): 218798
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NDA 218798 describes RILPIVIRINE HYDROCHLORIDE, which is a drug marketed by Somerset Theraps Llc and is included in one NDA. It is available from one supplier. Additional details are available on the RILPIVIRINE HYDROCHLORIDE profile page.
The generic ingredient in RILPIVIRINE HYDROCHLORIDE is rilpivirine hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
The generic ingredient in RILPIVIRINE HYDROCHLORIDE is rilpivirine hydrochloride. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
Summary for 218798
| Tradename: | RILPIVIRINE HYDROCHLORIDE |
| Applicant: | Somerset Theraps Llc |
| Ingredient: | rilpivirine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 218798
| Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 218798
Suppliers and Packaging for NDA: 218798
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RILPIVIRINE HYDROCHLORIDE | rilpivirine hydrochloride | TABLET;ORAL | 218798 | ANDA | Somerset Therapeutics, LLC | 70069-848 | 70069-848-30 | 30 TABLET, FILM COATED in 1 BOTTLE (70069-848-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jan 29, 2026 | TE: | AB | RLD: | No | ||||
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