Application 205302

Type: ANDA
Sponsor: STRIDES ARCOLAB LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RILPIVIRINE	RILPIVIRINE	TABLET;ORAL	25MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rilpivirine	RILPIVIRINE	Laurus Labs Limited	dadbf50d-6b7d-4fb5-bd9f-7769b048e764	2026-07-15	Warnings, Adverse reactions	Name fallback brand name: Rilpivirine generic name: RILPIVIRINE
Rilpivirine	RILPIVIRINE	Somerset Therapeutics, LLC	fb109de9-d88d-4405-8dd6-d458cbc387d1	2026-02-05	Warnings, Adverse reactions	Name fallback brand name: Rilpivirine generic name: RILPIVIRINE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32651	ORIG	2015-09-30

Application 205302

Related Records#

Application Products#

openFDA label cross-check#

Documents#