Application 077416

Type: ANDA
Sponsor: RANBAXY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERIDONE	RISPERIDONE	SOLUTION; ORAL	1MG/ML	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 4 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RISPERIDONE	RISPERIDONE	Chartwell RX, LLC	66390528-7517-452a-ae76-4338ec7db3ae	2023-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	NCS HealthCare of KY, LLC dba Vangard Labs	7bbc37f1-6d6a-4021-8976-1f103ce1cfbd	2023-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	bda104ac-1eea-4a1a-836a-24bcc034b90f	2022-11-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	2b9cce47-b8b3-4c9b-b26a-3d742a0db8e2	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	088dc3dd-7740-471b-8c06-5a47900ae5b5	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	1b5c9889-4dc3-48df-8629-4ac099e2b4c0	2022-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Sun Pharmaceutical Industries, Inc.	f91f551e-926f-440d-83d2-357e9d7484fe	2022-07-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Proficient Rx LP	394c7e27-52a2-4d4c-8c6e-fe37b03266ae	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
risperidone	RISPERIDONE	Proficient Rx LP	b611fe52-1787-47e6-8a6b-1999a4e4f22c	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: risperidone generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	ac152803-d75f-4c3c-bc49-8663b21a3a82	2019-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: RISPERIDONE generic name: RISPERIDONE
Risperidone	RISPERIDONE	Aphena Pharma Solutions - Tennessee, LLC	58e422ec-da66-41b0-83c1-aefd940beda0	2019-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Risperidone generic name: RISPERIDONE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31236	ORIG	2006-08-11