Home Applications 210714 Application 210714
Type ANDA
Sponsor BELOTECA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ISOSULFAN BLUE ISOSULFAN BLUE INJECTABLE;INJECTION 1% No No
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 A210714-001 ISOSULFAN BLUE ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210714-001 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 · 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 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS AP 2019-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210714-001 ISOSULFAN BLUE 50MG/5ML (10MG/ML) SOLUTION / SUBCUTANEOUS 2019-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION AP 2019-01-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A210714-001 ISOSULFAN BLUE 1% INJECTABLE / INJECTION 2019-01-16 e64feba35796…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-18 06:07:40 2026-07 A210714-001 AP 1 caaa826d4ba7…2019-07-19 19:46 UTC 2019-07 A210714-001 AP 1 ea99ee380514…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A210714-001 AP 1 a50c72e98297…
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.