Home Applications 205596 Application 205596
Type NDA
Sponsor MERCK SHARP DOHME Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NOXAFIL POSACONAZOLE SOLUTION;INTRAVENOUS 300MG/16.7ML (18MG/ML) Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N205596-001 NOXAFIL POSACONAZOLE 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD 2014-03-13
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N205596-001 10117951 2029-03-13 Drug product 2018-12-06 N205596-001 8410077 2029-03-13 Drug product 2014-04-08 N205596-001 9750822 2029-03-13 Drug product 2017-11-28 N205596-001 9358297 2031-06-24 U-3160 Drug product 2016-06-23 N205596-001 9358297 2031-06-24 U-3171 Drug product 2016-06-23 N205596-001 9358297 2031-06-24 U-4415 Drug product 2016-06-23 N205596-001 9358297 2031-06-24 U-4416 Drug product 2016-06-23 N205596-001 9023790 2031-07-04 U-1698 Drug product 2015-05-29 N205596-001 9023790 2031-07-04 U-3160 Drug product 2015-05-29 N205596-001 9023790 2031-07-04 U-3171 Drug product 2015-05-29 N205596-001 9023790 2031-07-04 U-4415 Drug product 2015-05-29 N205596-001 9023790 2031-07-04 U-4416 Drug product 2015-05-29 N205596-001 9493582 2033-02-27 Drug product 2016-12-15
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N205596-001 ODE-355 2028-06-17 N205596-001 NPP 2029-01-27
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 · 41 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 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD 2014-03-13 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2014-03-13 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N205596-001 NOXAFIL 300MG/16.7ML (18MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2014-03-13 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 9 · 353 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N205596-001 10117951 2029-03-13 Drug product 2018-12-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 8410077 2029-03-13 Drug product 2014-04-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9750822 2029-03-13 Drug product 2017-11-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9358297 2031-06-24 U-3171 Drug product 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9358297 2031-06-24 U-3160 Drug product 2016-06-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9023790 2031-07-04 U-3171 Drug product 2015-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9023790 2031-07-04 U-1698 Drug product 2015-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9023790 2031-07-04 U-3160 Drug product 2015-05-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N205596-001 9493582 2033-02-27 Drug product 2016-12-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 10117951 2029-03-13 Drug product 2018-12-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 8410077 2029-03-13 Drug product 2014-04-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9750822 2029-03-13 Drug product 2017-11-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9358297 2031-06-24 U-3171 Drug product 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9358297 2031-06-24 U-3160 Drug product 2016-06-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9023790 2031-07-04 U-3171 Drug product 2015-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9023790 2031-07-04 U-1698 Drug product 2015-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9023790 2031-07-04 U-3160 Drug product 2015-05-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N205596-001 9493582 2033-02-27 Drug product 2016-12-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N205596-001 10117951 2029-03-13 Drug product 2018-12-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 8410077 2029-03-13 Drug product 2014-04-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9750822 2029-03-13 Drug product 2017-11-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9358297 2031-06-24 U-3171 Drug product 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9358297 2031-06-24 U-3160 Drug product 2016-06-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9023790 2031-07-04 U-3171 Drug product 2015-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9023790 2031-07-04 U-1698 Drug product 2015-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9023790 2031-07-04 U-3160 Drug product 2015-05-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N205596-001 9493582 2033-02-27 Drug product 2016-12-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 10117951 2029-03-13 Drug product 2018-12-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 8410077 2029-03-13 Drug product 2014-04-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9750822 2029-03-13 Drug product 2017-11-28 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9358297 2031-06-24 U-3171 Drug product 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9358297 2031-06-24 U-3160 Drug product 2016-06-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9023790 2031-07-04 U-3171 Drug product 2015-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9023790 2031-07-04 U-1698 Drug product 2015-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9023790 2031-07-04 U-3160 Drug product 2015-05-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N205596-001 9493582 2033-02-27 Drug product 2016-12-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205596-001 10117951 2029-03-13 Drug product 2018-12-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205596-001 8410077 2029-03-13 Drug product 2014-04-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205596-001 9750822 2029-03-13 Drug product 2017-11-28 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N205596-001 9358297 2031-06-24 U-3171 Drug product 2016-06-23 b8a1b40f171c…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 87 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme LLC NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme LLC NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current 0085-4331 NOXAFIL posaconazole Merck Sharp & Dohme Corp. NDA Current