Home Applications 208075 Application 208075
Type ANDA
Sponsor APOTEX INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CEFTAROLINE FOSAMIL CEFTAROLINE FOSAMIL POWDER;INTRAVENOUS 400MG/VIAL No No 002 CEFTAROLINE FOSAMIL CEFTAROLINE FOSAMIL POWDER;INTRAVENOUS 600MG/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A208075-001 CEFTAROLINE FOSAMIL CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 A208075-002 CEFTAROLINE FOSAMIL CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21
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 2 · 66 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 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS AP 2021-09-21 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208075-001 CEFTAROLINE FOSAMIL 400MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a51e52b5d6a…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208075-002 CEFTAROLINE FOSAMIL 600MG/VIAL POWDER / INTRAVENOUS 2021-09-21 6a51e52b5d6a…
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.
Documents# Document, Submission type, Date table Document Submission type Date 57746 ORIG 2019-02-21