Home Applications 021506 Application 021506
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MYCAMINE MICAFUNGIN SODIUM INJECTABLE; INJECTION 50MG No No 002 MYCAMINE MICAFUNGIN SODIUM INJECTABLE;INTRAVENOUS EQ 50MG BASE/VIAL Yes Yes 003 MYCAMINE MICAFUNGIN SODIUM INJECTABLE;INTRAVENOUS EQ 100MG BASE/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
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 N021506-002 MYCAMINE MICAFUNGIN SODIUM EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-16 N021506-003 MYCAMINE MICAFUNGIN SODIUM EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-06-27
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 3 · 88 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 2026-10-15 13:18:30 2026-09 N021506-002 MYCAMINE EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021506-003 MYCAMINE EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-06-27 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021506-002 MYCAMINE EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021506-003 MYCAMINE EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-06-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021506-002 MYCAMINE EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2005-03-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021506-003 MYCAMINE EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INTRAVENOUS RLD 2006-06-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2006-06-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2005-03-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS RLD 2006-06-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021506-002 MYCAMINE EQ 50MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2005-03-16 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N021506-003 MYCAMINE EQ 100MG BASE/VIAL INJECTABLE / INTRAVENOUS AP RLD, RS 2006-06-27 4b0b4de00fa7…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 76 observed states.
Observed Orange Book patent history# Patent history page 2 of 2 · 79 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2021-03-12 10:30 UTC 2021-03 N021506-003 6774104*PED 2021-07-08 Pediatric extension 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021506-002 6774104 2021-01-08 U-650 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021506-002 6774104 2021-01-08 U-845 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021506-002 6774104*PED 2021-07-08 Pediatric extension 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021506-003 6774104 2021-01-08 U-845 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021506-003 6774104 2021-01-08 U-650 Drug product 8869cabd3fbd…2020-12-22 03:56 UTC 2020-12 N021506-003 6774104*PED 2021-07-08 Pediatric extension 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021506-002 6774104 2021-01-08 U-650 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021506-002 6774104 2021-01-08 U-845 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021506-002 6774104*PED 2021-07-08 Pediatric extension c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021506-003 6774104 2021-01-08 U-845 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021506-003 6774104 2021-01-08 U-650 Drug product c0c555d07b60…2020-11-12 02:37 UTC 2020-11 N021506-003 6774104*PED 2021-07-08 Pediatric extension c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021506-002 6107458 2019-03-16 U-845 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-002 6107458 2019-03-16 U-650 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-002 6774104 2021-01-08 U-845 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-002 6774104 2021-01-08 U-650 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-002 6774104*PED 2021-07-08 Pediatric extension 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-003 6107458 2019-03-16 U-845 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-003 6107458 2019-03-16 U-650 Drug substance, Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-003 6774104 2021-01-08 U-845 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-003 6774104 2021-01-08 U-650 Drug product 3f01610625f2…2019-12-14 00:12 UTC 2019-12 N021506-003 6774104*PED 2021-07-08 Pediatric extension 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021506-002 6107458 2019-03-16 U-845 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-002 6107458 2019-03-16 U-650 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-002 6774104 2021-01-08 U-845 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-002 6774104 2021-01-08 U-650 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-003 6107458 2019-03-16 U-845 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-003 6107458 2019-03-16 U-650 Drug substance, Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-003 6774104 2021-01-08 U-845 Drug product b00525d2431f…2019-09-15 20:21 UTC 2019-09 N021506-003 6774104 2021-01-08 U-650 Drug product b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021506-002 6107458 2019-03-16 U-845 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-002 6107458 2019-03-16 U-650 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-002 6774104 2021-01-08 U-845 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-002 6774104 2021-01-08 U-650 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-003 6107458 2019-03-16 U-845 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-003 6107458 2019-03-16 U-650 Drug substance, Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-003 6774104 2021-01-08 U-845 Drug product ea99ee380514…2019-07-19 19:46 UTC 2019-07 N021506-003 6774104 2021-01-08 U-650 Drug product ea99ee380514…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 68 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 · 5 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 19 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0469-3211 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3211 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin sodium Astellas Pharma US, Inc. NDA Current 0469-3250 Mycamine Micafungin Sodium Astellas Pharma US, Inc. NDA Current