Home Applications 050778 Application 050778
Type NDA
Sponsor PFIZER INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ELLENCE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 200MG/100ML (2MG/ML) Yes Yes 002 ELLENCE EPIRUBICIN HYDROCHLORIDE INJECTABLE;INJECTION 50MG/25ML (2MG/ML) Yes 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 N050778-001 ELLENCE EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 N050778-002 ELLENCE EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15
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 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 84e616aacf4f…2026-09-14 22:38:34 2026-08 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N050778-001 ELLENCE 200MG/100ML (2MG/ML) INJECTABLE / INJECTION AP RLD, RS 1999-09-15 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N050778-002 ELLENCE 50MG/25ML (2MG/ML) INJECTABLE / INJECTION AP RLD 1999-09-15 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Ellence EPIRUBICIN HYDROCHLORIDE Pharmacia & Upjohn Company LLC 0a03c798-a652-4895-b29c-3b521a89ba42 2026-07-24 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 050778 application number: NDA050778 ndc (product): 0009-5091 ndc (product): 0009-5093
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 14 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0009-5091 Ellence epirubicin hydrochloride Pharmacia & Upjohn Company LLC NDA Current 0009-5091 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5091 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5091 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5091 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5091 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5091 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia & Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current 0009-5093 Ellence epirubicin hydrochloride Pharmacia and Upjohn Company LLC NDA Current