FDA.reportPublic FDA data

Application 205801

Type
ANDA
Sponsor
WEST-WARD PHARMS INT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RITONAVIRRITONAVIRCAPSULE;ORAL100MGNoYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A205801-001RITONAVIRRITONAVIR100MGCAPSULE / ORAL2020-12-03

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205801-001RITONAVIR100MGCAPSULE / ORAL2020-12-03a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
NorvirRITONAVIRAbbVie Inc.2849298e-de6e-47bb-8194-56e075b33fc32024-07-03Boxed warning, Warnings, Adverse reactionsName fallback
generic name: RITONAVIR
RitonavirRITONAVIRAmerican Health Packaging19503bc4-3443-4ad4-aa27-437f4f3288b12024-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR
RitonavirRITONAVIRAurobindo Pharma Limited11f757f1-cf48-47a8-925e-918359cbd2d42023-11-13Boxed 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
RitonavirRITONAVIRAmneal Pharmaceuticals LLCa32cb2e3-d4e5-4bbf-9d88-20b2b249e7792020-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ritonavir
generic name: RITONAVIR

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
55402ORIG2018-09-07