FDA.reportPublic FDA data

Application 205040

Type
NDA
Sponsor
CIPLA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RITONAVIRRITONAVIRTABLET; ORAL25MGYesNo
002RITONAVIRRITONAVIRTABLET; ORAL50MGNoNo

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 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RitonavirRITONAVIRAmneal Pharmaceuticals LLCa32cb2e3-d4e5-4bbf-9d88-20b2b249e7792026-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR
NorvirRITONAVIRAbbVie Inc.2849298e-de6e-47bb-8194-56e075b33fc32026-07-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
RitonavirRITONAVIRBryant Ranch Prepackd2f8c6ba-5e06-4b03-8ca5-b4fd7e5a89252026-03-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR
RitonavirRITONAVIRNuCare Pharmaceuticals, Inc.3f92f1e2-59f4-f6c4-e063-6294a90a487b2025-09-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR
RitonavirRITONAVIRBryant Ranch Prepack3c811e3e-f685-4af7-a4d1-037f2613ee682025-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR
RitonavirRITONAVIRAmerican Health Packaging19503bc4-3443-4ad4-aa27-437f4f3288b12024-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR
RitonavirRITONAVIRCamber Pharmaceuticals, Inc.db633374-6d8e-4622-9fe1-f9d68baa59bb2023-02-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: 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
10419ORIG2015-04-03