Home Applications 091540 Application 091540
Type ANDA
Sponsor MYLAN LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 PACLITAXEL PACLITAXEL INJECTABLE;INJECTION 6MG/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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A091540-001 PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29
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 2 · 41 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 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2011-09-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091540-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION 2011-09-29 cb3db0bc1861…
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 Natco Pharma USA LLC a1eb16b4-285b-4e81-9c4e-1244d4a52af8 2026-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 091540 application number: ANDA091540
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67457-434 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-434 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-434 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-434 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-449 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-449 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-449 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-449 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-471 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-471 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-471 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current 67457-471 Paclitaxel Paclitaxel Mylan Institutional LLC ANDA Current