Home Applications 022142 Application 022142
Type NDA
Sponsor MYLAN LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE TABLET;ORAL 600MG;300MG;300MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N022142-001 SYMFI EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022142-001 AB
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 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL RLD, RS 2018-03-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022142-001 SYMFI 600MG;300MG;300MG TABLET / ORAL AB RLD, RS 2018-03-22 cb3db0bc1861…
Observed Orange Book normalized TE history# 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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SYMFI EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE Viatris Specialty LLC 81a55dd9-78a8-49c3-88ab-8f5bffafa359 2019-10-15 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 022142 application number: NDA022142 ndc (product): 49502-475
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49502-475 SYMFI Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Mylan Specialty L.P. NDA Current 49502-475 SYMFI Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Mylan Specialty L.P. NDA Current 49502-475 SYMFI Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate Mylan Specialty L.P. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 60725 SUPPL 2019-10-30 60714 SUPPL 2019-10-30 56559 ORIG 2018-11-26 6950 ORIG 2018-03-26 53141 ORIG 2018-03-22 62974 ORIG 1900-01-01