Home Applications 206110 Application 206110
Type NDA
Sponsor FRESENIUS KABI USA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE POWDER;INTRAVENOUS 50MG/VIAL No No 002 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE POWDER;INTRAVENOUS 70MG/VIAL No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N206110-001 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 N206110-002 CASPOFUNGIN ACETATE CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N206110-001 9636407 2032-12-21 Drug product 2017-05-10 N206110-002 9636407 2032-12-21 Drug product 2017-05-10
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 · 84 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 2026-08-18 06:07:40 2026-07 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206110-001 CASPOFUNGIN ACETATE 50MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206110-002 CASPOFUNGIN ACETATE 70MG/VIAL POWDER / INTRAVENOUS AP 2016-12-30 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 84 observed states.
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N206110-001 9636407 2032-12-21 Drug product 2017-05-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N206110-002 9636407 2032-12-21 Drug product 2017-05-10 bb7c543d1eb4…
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 63323-356 Caspofungin Acetate Caspofungin Acetate Fresenius Kabi USA, LLC NDA Current 63323-356 Caspofungin Acetate Caspofungin Acetate Fresenius Kabi USA, LLC NDA Current 63323-358 Caspofungin Acetate Caspofungin Acetate Fresenius Kabi USA, LLC NDA Current 63323-358 Caspofungin Acetate Caspofungin Acetate Fresenius Kabi USA, LLC NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 66990 SUPPL 2021-04-05 66984 SUPPL 2021-04-02 54829 SUPPL 2018-07-06 54767 SUPPL 2018-07-05 50206 ORIG 2017-10-27 50204 ORIG 2017-10-27 46668 ORIG 2017-01-05 46658 ORIG 2017-01-03