Home Applications 216338 Application 216338
Type NDA
Sponsor TEVA PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PACLITAXEL PACLITAXEL INJECTABLE;INJECTION 100MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N216338-001 PACLITAXEL PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N216338-001 AB
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 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD 2023-05-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD 2023-05-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD 2023-05-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS RLD, RS 2023-05-11 3f0d92c62455…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216338-001 PACLITAXEL 100MG/VIAL POWDER / INTRAVENOUS AB RLD, RS 2023-05-11 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 Paclitaxel PACLITAXEL Teva Pharmaceuticals, Inc. 15dd51ed-29e8-468b-b6d1-21b1f84d6f2e 2023-11-01 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 216338 application number: NDA216338
Documents# Document, Submission type, Date table Document Submission type Date 77400 ORIG 2024-02-06 76658 SUPPL 2023-11-24 76646 SUPPL 2023-11-22 74231 ORIG 2023-05-12 71585 ORIG 2022-07-18