Home Applications 078589 Application 078589
Type ANDA
Sponsor ACTAVIS TOTOWA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 40MG/2ML (20MG/ML) No No 002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 100MG/5ML (20MG/ML) No No 003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE INJECTABLE;INJECTION 500MG/25ML (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 A078589-001 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 A078589-002 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 A078589-003 IRINOTECAN HYDROCHLORIDE IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18
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 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078589-002 IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078589-003 IRINOTECAN HYDROCHLORIDE 500MG/25ML (20MG/ML) INJECTABLE / INJECTION AP 2015-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078589-001 IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) INJECTABLE / INJECTION AP 2008-02-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current 45963-614 Irinotecan hydrochloride Irinotecan hydrochloride Actavis Pharma, Inc. ANDA Current