Home NDC 73358-210 Docetaxel Anhydrous
Product NDC 73358-210
11-digit product format 733580210
Labeler code 73358
Product ID 73358-210_35fab376-0ff9-4227-b780-4bf3ffd0bccc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Docetaxel Anhydrous
Dosage form INJECTION
Route INTRAVENOUS
Labeler Curae Pharma360 Inc.
Application ANDA209634
Marketing category ANDA
Marketing start 2022-10-17
Marketing end 0000-00-00
Substance DOCETAXEL ANHYDROUS
Active strength 10 mg/mL
Pharmacologic classes Microtubule Inhibition [PE], Microtubule Inhibitor [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 36 matching rows.
View current auxiliary records. · View the auxiliary file history.
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 A209634-001 DOCETAXEL DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 A209634-002 DOCETAXEL DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 A209634-003 DOCETAXEL DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24
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 4 · 123 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 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209634-002 DOCETAXEL 80MG/8ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209634-003 DOCETAXEL 160MG/16ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209634-001 DOCETAXEL 20MG/2ML (10MG/ML) INJECTABLE / INJECTION AP 2018-08-24 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 99 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 73358-210-08 73358021008 1 VIAL, MULTI-DOSE in 1 CARTON (73358-210-08) > 8 mL in 1 VIAL, MULTI-DOSE 2022-10-17 0000-00-00 No No Current 73358-210-16 73358021016 1 VIAL, MULTI-DOSE in 1 CARTON (73358-210-16) > 16 mL in 1 VIAL, MULTI-DOSE 2022-10-17 0000-00-00 No No Current