Home Applications 022335 Application 022335
Type NDA
Sponsor CYCLOMEDICA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TECHNEGAS KIT TECHNETIUM TC-99M LABELED CARBON AEROSOL;INHALATION N/A Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 N022335-001 TECHNEGAS KIT TECHNETIUM TC-99M LABELED CARBON N/A AEROSOL / INHALATION RLD, RS 2023-09-29
Orange Book patents# Current patent rows page 1 of 1 · 1 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022335-001 7722856 2031-02-24 U-4442 2026-03-13
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N022335-001 NP 2026-09-29
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.
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 2026-09-14 22:38:34 2026-08 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 9b2671bbb829…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022335-001 TECHNEGAS KIT N/A AEROSOL / INHALATION RLD, RS 2023-09-29 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N022335-001 7722856 2031-02-24 U-4442 2026-03-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 N022335-001 7722856 2031-02-24 U-4442 2026-03-13 caaa826d4ba7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N022335-001 7722856 2031-02-24 U-4442 2026-03-13 a50c72e98297…
Observed Orange Book exclusivity history# 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join TECHNEGAS KIT FOR THE PREPARATION OF TECHNETIUM TC 99M-LABELED CARBON INHALATION AEROSOL Cyclomedica Australia Pty Limited 10ab1c14-3e01-e12b-e063-6394a90aea2f 2026-02-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 022335 application number: NDA022335 TECHNEGAS KIT FOR THE PREPARATION OF TECHNETIUM TC 99M-LABELED CARBON INHALATION AEROSOL Cyclomedica Australia Pty Limited 10320da4-0c64-4d03-e063-6394a90a1923 2026-02-10 Warnings, Adverse reactions Exact identifier application applno (NDA): 022335 application number: NDA022335
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 77399 ORIG 2024-02-05 77397 ORIG 2024-02-05 77393 ORIG 2024-02-02