Home Applications 090130 Application 090130
Type ANDA
Sponsor ACTAVIS TOTOWA 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 A090130-001 PACLITAXEL PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090130-001 AP
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 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A090130-001 PACLITAXEL 6MG/ML INJECTABLE / INJECTION AP 2009-12-09 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Paclitaxel PACLITAXEL Fresenius Kabi USA, LLC a6c24189-293f-42ca-b969-75870bb55af0 2024-09-19 Boxed warning, Warnings, Adverse reactions Exact identifier ndc (product): 63323-763
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 8 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 45963-613 Paclitaxel Paclitaxel Actavis Pharma, Inc. ANDA Current 63323-763 Paclitaxel Paclitaxel Fresenius Kabi USA, LLC ANDA Current