FDA.reportPublic FDA data

Application 202990

Type
ANDA
Sponsor
PAR FORMULATIONS PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EFAVIRENZEFAVIRENZTABLET; ORAL600MGNoNo

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
brand name: Efavirenz
generic name: EFAVIRENZ
EfavirenzEFAVIRENZCipla USA Inc.92603fa5-7a2c-4bfb-9a70-aadb4fba952c2024-03-31Warnings, Adverse reactionsName fallback
brand name: Efavirenz
generic name: EFAVIRENZ
EfavirenzEFAVIRENZAurobindo Pharma Limited4c57ad7f-321a-46c8-851a-c895466eb8e12023-12-29Warnings, Adverse reactionsName fallback
brand name: Efavirenz
generic name: EFAVIRENZ
EfavirenzEFAVIRENZAurobindo Pharma Limitedc5eedb5d-4cab-4056-a14a-ffdf677013552023-12-29Warnings, Adverse reactionsName fallback
brand name: Efavirenz
generic name: EFAVIRENZ
EfavirenzEFAVIRENZCamber Pharmaceuticals, Inc.6d625901-fef2-4c93-9619-f8991d65413d2023-05-15Warnings, Adverse reactionsName fallback
brand name: Efavirenz
generic name: EFAVIRENZ
EFAVIRENZEFAVIRENZXLCare Pharmaceuticals Inc.966b815d-1d78-4b54-8f00-c5a0b67c78be2023-01-12Warnings, Adverse reactionsName fallback
brand name: EFAVIRENZ
generic name: EFAVIRENZ

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32346ORIG2012-06-28