Home Applications 209639 Application 209639
Type ANDA
Sponsor BIOCON PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 7MG No No 002 TERIFLUNOMIDE TERIFLUNOMIDE TABLET;ORAL 14MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209639-001 TERIFLUNOMIDE TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 A209639-002 TERIFLUNOMIDE TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 · 46 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 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209639-001 TERIFLUNOMIDE 7MG TABLET / ORAL AB 2023-03-13 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A209639-002 TERIFLUNOMIDE 14MG TABLET / ORAL AB 2023-03-13 a67488948f0b…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 46 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.