Home Applications 216677 Application 216677
Type ANDA
Sponsor HERITAGE Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 20MG/ML (20MG/ML) No No 002 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 80MG/4ML (20MG/ML) No No 003 DOCETAXEL DOCETAXEL INJECTABLE;INJECTION 160MG/8ML (20MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A216677-001 DOCETAXEL DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 A216677-002 DOCETAXEL DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 A216677-003 DOCETAXEL DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26
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.
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 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216677-001 DOCETAXEL 20MG/ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216677-002 DOCETAXEL 80MG/4ML (20MG/ML) INJECTABLE / INJECTION AP 2024-02-28 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216677-003 DOCETAXEL 160MG/8ML (20MG/ML) INJECTABLE / INJECTION AP 2024-11-26 a50c72e98297…
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 Docetaxel DOCETAXEL Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. 81686d37-a13f-46e2-b439-a84eb1433634 2026-03-19 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216677 application number: ANDA216677