Home Applications 065361 Application 065361
Type ANDA
Sponsor CIPLA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) No No 002 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A065361-001 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 A065361-002 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 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 3 · 86 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 2026-09-14 22:38:34 2026-08 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A065361-001 EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A065361-002 EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP 2007-10-22 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 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 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 25021-203 Epirubicin Hydrochloride epirubicin hydrochloride Sagent Pharmaceuticals ANDA Current 25021-203 Epirubicin Hydrochloride epirubicin hydrochloride Sagent Pharmaceuticals ANDA Current 59923-701 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE Areva Pharmaceuticals,Inc. ANDA Current 59923-701 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE Areva Pharmaceuticals,Inc. ANDA Current 59923-701 EPIRUBICIN HYDROCHLORIDE EPIRUBICIN HYDROCHLORIDE Areva Pharmaceuticals,Inc. ANDA Current