Home Applications 201195 Application 201195
Type NDA
Sponsor ACCORD HLTHCARE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 20MG/0.5ML (40MG/ML) Yes No 002 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 80MG/2ML (40MG/ML) Yes No 003 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 20MG/ML (20MG/ML) Yes No 004 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 80MG/4ML (20MG/ML) Yes No 005 DOCETAXEL 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 · 5 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N201195-001 DOCETAXEL DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 N201195-002 DOCETAXEL DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 N201195-003 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 N201195-004 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 N201195-005 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20
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 6 · 205 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 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-001 DOCETAXEL 20MG/0.5ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-002 DOCETAXEL 80MG/2ML (40MG/ML) INJECTABLE / INJECTION RLD 2011-06-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-003 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-004 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP RLD 2012-04-20 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201195-005 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP RLD, RS 2012-04-20 5bbf6a4d5a75…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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 · 7 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 16729-231 Docetaxel Docetaxel Accord Healthcare Inc. NDA Current 16729-267 Docetaxel Docetaxel Accord Healthcare Inc. NDA Current 16729-267 DOCETAXEL docetaxel Accord Healthcare Inc. NDA Current 16729-267 DOCETAXEL docetaxel Accord Healthcare Inc. NDA Current 16729-267 DOCETAXEL docetaxel Accord Healthcare Inc. NDA Current 63739-932 Docetaxel Docetaxel McKesson Packaging Services a business unit of McKesson Corporation NDA Current 63739-971 Docetaxel Docetaxel McKesson Packaging Services a business unit of McKesson Corporation NDA Current