Home Applications 022572 Application 022572
Type NDA
Sponsor MOBIUS THERAP Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MITOSOL MITOMYCIN FOR SOLUTION;TOPICAL 0.2MG/VIAL Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N022572-001 MITOSOL MITOMYCIN 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07
Orange Book patents# Current patent rows page 1 of 1 · 5 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022572-001 8186511 2026-07-19 Drug product 2012-06-25 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 N022572-001 9649428 2029-05-21 U-2095 2017-06-09
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 · 42 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 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022572-001 MITOSOL 0.2MG/VIAL FOR SOLUTION / TOPICAL RLD, RS 2012-02-07 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 6 · 210 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 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 8186511 2026-07-19 Drug product 2012-06-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 9205075 2026-07-19 Drug product 2016-01-06 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 9539241 2028-01-02 U-2095 Drug substance, Drug product 2017-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 7806265 2029-02-01 Drug product 2012-03-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022572-001 9649428 2029-05-21 U-2095 2017-06-09 2680178bc6a6…
Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2019-12-13 00:20 UTC 2019-12 N022572-001 ODE-21 2019-02-07 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N022572-001 ODE-21 2019-02-07 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022572-001 ODE-21 2019-02-07 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022572-001 ODE-21 2019-02-07 ea99ee380514…
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 49771-002 Mitosol mitomycin Mobius Therapeutics LLC NDA Current 49771-002 Mitosol mitomycin Mobius Therapeutics LLC NDA Current 49771-002 Mitosol mitomycin Mobius Therapeutics LLC NDA Current 49771-002 Mitosol mitomycin Mobius Therapeutics LLC NDA Current