Home Applications 090874 Application 090874
Type ANDA
Sponsor MYLAN INSTITUTIONAL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISOSULFAN BLUE ISOSULFAN BLUE INJECTABLE;INJECTION 1% No Yes 002 ISOSULFAN BLUE ISOSULFAN BLUE SOLUTION;SUBCUTANEOUS 10MG/ML (10MG/ML) No Yes 003 ISOSULFAN BLUE ISOSULFAN BLUE SOLUTION;SUBCUTANEOUS 30MG/3ML (10MG/ML) No Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A090874-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 A090874-002 ISOSULFAN BLUE ISOSULFAN BLUE 10MG/ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28 A090874-003 ISOSULFAN BLUE ISOSULFAN BLUE 30MG/3ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090874-001 AP
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 · 45 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 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090874-002 ISOSULFAN BLUE 10MG/ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A090874-003 ISOSULFAN BLUE 30MG/3ML (10MG/ML) SOLUTION / SUBCUTANEOUS RS 2026-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090874-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP RS 2010-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090874-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP RS 2010-07-20 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 3 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 67457-220 Isosulfan Blue Isosulfan Blue Mylan Institutional LLC ANDA Current 67457-220 Isosulfan Blue Isosulfan Blue Mylan Institutional LLC ANDA Current 67457-586 Isosulfan Blue Isosulfan Blue Mylan Institutional LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9303 ORIG 2010-07-27