FDA.reportPublic FDA data

Application 091471

Type
ANDA
Sponsor
MYLAN

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A091471-001EFAVIRENZEFAVIRENZ600MGTABLET / ORAL2016-02-17

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A091471-001EFAVIRENZ600MGTABLET / ORAL2016-02-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A091471-001EFAVIRENZ600MGTABLET / ORAL2016-02-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A091471-001EFAVIRENZ600MGTABLET / ORAL2016-02-17cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A091471-001EFAVIRENZ600MGTABLET / ORAL2016-02-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A091471-001AB174a2ff9319b5…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091471-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A091471-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091471-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091471-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091471-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A091471-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A091471-001AB1ea99ee380514…

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 · 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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
0378-2233EfavirenzefavirenzMylan Pharmaceuticals Inc.ANDACurrent
70518-1013EfavirenzefavirenzREMEDYREPACK INC.ANDACurrent
70518-1013EfavirenzefavirenzREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39616ORIG2016-02-23
31532ORIG2016-02-19