Details for New Drug Application (NDA): 219788
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NDA 219788 describes RILPIVIRINE HYDROCHLORIDE, which is a drug marketed by Laurus and Somerset Theraps Llc and is included in two NDAs. It is available from two suppliers. Additional details are available on the RILPIVIRINE HYDROCHLORIDE profile page.
The generic ingredient in RILPIVIRINE HYDROCHLORIDE is rilpivirine hydrochloride. There is one drug master file entry for this compound. Three 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 is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the rilpivirine hydrochloride profile page.
Summary for 219788
| Tradename: | RILPIVIRINE HYDROCHLORIDE |
| Applicant: | Laurus |
| Ingredient: | rilpivirine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 219788
| Mechanism of Action | Non-Nucleoside Reverse Transcriptase Inhibitors |
Medical Subject Heading (MeSH) Categories for 219788
Suppliers and Packaging for NDA: 219788
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RILPIVIRINE HYDROCHLORIDE | rilpivirine hydrochloride | TABLET;ORAL | 219788 | ANDA | Laurus Labs Limited | 42385-999 | 42385-999-30 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-999-30) |
| RILPIVIRINE HYDROCHLORIDE | rilpivirine hydrochloride | TABLET;ORAL | 219788 | ANDA | Laurus Labs Limited | 42385-999 | 42385-999-31 | 30 TABLET, FILM COATED in 1 BOTTLE (42385-999-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 25MG BASE | ||||
| Approval Date: | Jul 10, 2026 | TE: | AB | RLD: | No | ||||
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