FDA.reportPublic FDA data

Application 205425

Type
NDA
Sponsor
CIPLA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LOPINAVIR AND RITONAVIRLOPINAVIR;RITONAVIRPELLETS;ORAL40MG;10MGNoNo

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 ยท 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lopinavir and RitonavirLOPINAVIR AND RITONAVIRMacleods Pharmaceuticals Limited115178c8-5ee2-4d96-820e-ea8264c1ac102026-08-27Warnings, Adverse reactionsName fallback
brand name: Lopinavir and Ritonavir
Lopinavir and RitonavirLOPINAVIR AND RITONAVIRLaurus Labs Limiteda7072c60-6dbf-4125-95e7-497c05a9e6a62023-10-20Warnings, Adverse reactionsName fallback
brand name: Lopinavir and Ritonavir
Lopinavir and ritonavirLOPINAVIR AND RITONAVIRCamber Pharmaceuticals, Inc.4e5005b8-f00c-4671-be09-bb927190760f2021-06-03Warnings, Adverse reactionsName fallback
brand name: Lopinavir and ritonavir

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
10446ORIG2015-05-22