Home Applications 211407 Application 211407
Type ANDA
Sponsor CHARTWELL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 67MG No No 002 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 134MG No No 003 FENOFIBRATE (MICRONIZED) FENOFIBRATE CAPSULE;ORAL 200MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211407-001 FENOFIBRATE (MICRONIZED) FENOFIBRATE 67MG CAPSULE / ORAL AB 2024-01-31 A211407-002 FENOFIBRATE (MICRONIZED) FENOFIBRATE 134MG CAPSULE / ORAL AB 2024-01-31 A211407-003 FENOFIBRATE (MICRONIZED) FENOFIBRATE 200MG CAPSULE / ORAL AB 2024-01-31
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 · 54 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 2026-08-18 06:07:40 2026-07 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211407-002 FENOFIBRATE (MICRONIZED) 134MG CAPSULE / ORAL AB 2024-01-31 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211407-003 FENOFIBRATE (MICRONIZED) 200MG CAPSULE / ORAL AB 2024-01-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211407-001 FENOFIBRATE (MICRONIZED) 67MG CAPSULE / ORAL AB 2024-01-31 1e350fbaab3a…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 54 observed states.
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.