Home Applications 020449 Application 020449
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TAXOTERE DOCETAXEL INJECTABLE;INJECTION 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 003 TAXOTERE DOCETAXEL INJECTABLE;INJECTION 20MG/ML (20MG/ML) Yes Yes 004 TAXOTERE DOCETAXEL INJECTABLE;INJECTION 80MG/4ML (20MG/ML) Yes Yes 005 TAXOTERE DOCETAXEL INJECTABLE;INJECTION 160MG/8ML (20MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020449-001 TAXOTERE DOCETAXEL 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 N020449-003 TAXOTERE DOCETAXEL 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2010-08-03 N020449-004 TAXOTERE DOCETAXEL 80MG/4ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 2010-08-02 N020449-005 TAXOTERE DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020449-005 AP
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 5 · 164 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 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION RLD 2010-08-02 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020449-001 TAXOTERE 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD 1996-05-14 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020449-003 TAXOTERE 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-03 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020449-004 TAXOTERE 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2010-08-02 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020449-005 TAXOTERE 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-13 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 115 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 34 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0075-8003 TAXOTERE Docetaxel Sanofi-Aventis U.S. LLC NDA Current 0075-8003 TAXOTERE Docetaxel sanofi-aventis U.S. LLC NDA Current 0075-8003 TAXOTERE Docetaxel Sanofi-Aventis U.S. LLC NDA Current 0075-8004 TAXOTERE Docetaxel Sanofi-Aventis U.S. LLC NDA Current 0075-8004 TAXOTERE Docetaxel sanofi-aventis U.S. LLC NDA Current 0075-8004 TAXOTERE Docetaxel Sanofi-Aventis U.S. LLC NDA Current 0075-8004 TAXOTERE Docetaxel Sanofi-Aventis U.S. LLC NDA Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1020 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1021 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current 0955-1022 Docetaxel Docetaxel Winthrop U.S. NDA AUTHORIZED GENERIC Current