FDA.reportPublic FDA data

Application 022420

Type
NDA
Sponsor
STRIDES ARCOLAB LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFAVIRENZ 200MG SCORED TABLETSEFAVIRENZTABLET; ORAL200MGNoNo

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 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EfavirenzEFAVIRENZMacleods Pharmaceuticals Limited13ca3456-e5bf-4bb1-af95-b1378658a3582024-06-28Warnings, Adverse reactionsName fallback
generic name: EFAVIRENZ
EfavirenzEFAVIRENZCipla USA Inc.92603fa5-7a2c-4bfb-9a70-aadb4fba952c2024-03-31Warnings, Adverse reactionsName fallback
generic name: EFAVIRENZ
EfavirenzEFAVIRENZAurobindo Pharma Limited4c57ad7f-321a-46c8-851a-c895466eb8e12023-12-29Warnings, Adverse reactionsName fallback
generic name: EFAVIRENZ
EfavirenzEFAVIRENZAurobindo Pharma Limitedc5eedb5d-4cab-4056-a14a-ffdf677013552023-12-29Warnings, Adverse reactionsName fallback
generic name: EFAVIRENZ
EfavirenzEFAVIRENZCamber Pharmaceuticals, Inc.6d625901-fef2-4c93-9619-f8991d65413d2023-05-15Warnings, Adverse reactionsName fallback
generic name: EFAVIRENZ
EFAVIRENZEFAVIRENZXLCare Pharmaceuticals Inc.966b815d-1d78-4b54-8f00-c5a0b67c78be2023-01-12Warnings, Adverse reactionsName fallback
generic name: EFAVIRENZ

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
29707ORIG2010-03-10