Application 202860
- Type
- NDA
- Sponsor
- VERO BIOTECH
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | GENOSYL | NITRIC OXIDE | GAS;INHALATION | 800PPM | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202860-001 | GENOSYL | NITRIC OXIDE | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202860-001 | 8057742 | 2026-01-18 | U-3037 | 2021-01-15 | |
| N202860-001 | 7618594 | 2026-10-17 | Drug product | 2020-06-10 | |
| N202860-001 | 7947227 | 2026-10-17 | U-3037 | 2021-01-15 | |
| N202860-001 | 7560076 | 2027-04-21 | Drug product | 2020-06-10 | |
| N202860-001 | 9701538 | 2029-01-28 | Drug product | 2021-01-15 | |
| N202860-001 | 10926054 | 2029-08-13 | Drug product | 2021-03-09 | |
| N202860-001 | 8944049 | 2029-08-13 | Drug product | 2021-01-15 | |
| N202860-001 | 9604028 | 2029-08-13 | U-2793 | 2020-05-05 | |
| N202860-001 | 11511252 | 2029-09-21 | Drug product | 2023-01-11 | |
| N202860-001 | 11103669 | 2030-06-21 | Drug product | 2021-09-23 | |
| N202860-001 | 8607785 | 2030-07-14 | Drug product | 2021-01-15 | |
| N202860-001 | 10737051 | 2035-10-20 | Drug product | 2020-08-21 | |
| N202860-001 | 10213572 | 2036-02-12 | Drug product | 2020-05-05 | |
| N202860-001 | 11672938 | 2040-07-22 | U-3037 | 2023-07-14 |
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 | 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 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 4b0b4de00fa7… | |
| 2022-03-09 01:35 UTC | 2022-03 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | c0c555d07b60… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N202860-001 | GENOSYL | 800PPM | GAS / INHALATION | RLD, RS | 2019-12-20 | a50c72e98297… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 8057742 | 2026-01-18 | U-3037 | 2021-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 7618594 | 2026-10-17 | Drug product | 2020-06-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 7947227 | 2026-10-17 | U-3037 | 2021-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 7560076 | 2027-04-21 | Drug product | 2020-06-10 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 9701538 | 2029-01-28 | Drug product | 2021-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 10926054 | 2029-08-13 | Drug product | 2021-03-09 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 8944049 | 2029-08-13 | Drug product | 2021-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 9604028 | 2029-08-13 | U-2793 | 2020-05-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 11511252 | 2029-09-21 | Drug product | 2023-01-11 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 11103669 | 2030-06-21 | Drug product | 2021-09-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 8607785 | 2030-07-14 | Drug product | 2021-01-15 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 10737051 | 2035-10-20 | Drug product | 2020-08-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 10213572 | 2036-02-12 | Drug product | 2020-05-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202860-001 | 11672938 | 2040-07-22 | U-3037 | 2023-07-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 10124142 | 2025-08-18 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 11291793 | 2025-08-18 | Drug product | 2022-05-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 11383059 | 2025-08-18 | U-3037 | 2022-08-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 11554241 | 2025-08-18 | U-3037 | 2023-04-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 8226916 | 2025-08-18 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 8609028 | 2025-08-18 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 8821801 | 2025-08-18 | Drug product | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 9522249 | 2025-08-18 | Drug product | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 9956373 | 2025-08-18 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 10814092 | 2025-10-17 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 8057742 | 2026-01-18 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 7618594 | 2026-10-17 | Drug product | 2020-06-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 7947227 | 2026-10-17 | U-3037 | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 7560076 | 2027-04-21 | Drug product | 2020-06-10 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 9701538 | 2029-01-28 | Drug product | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 10926054 | 2029-08-13 | Drug product | 2021-03-09 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 8944049 | 2029-08-13 | Drug product | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 9604028 | 2029-08-13 | U-2793 | 2020-05-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 11511252 | 2029-09-21 | Drug product | 2023-01-11 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 11103669 | 2030-06-21 | Drug product | 2021-09-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 8607785 | 2030-07-14 | Drug product | 2021-01-15 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 10737051 | 2035-10-20 | Drug product | 2020-08-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 10213572 | 2036-02-12 | Drug product | 2020-05-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202860-001 | 11672938 | 2040-07-22 | U-3037 | 2023-07-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202860-001 | 10124142 | 2025-08-18 | U-3037 | 2021-01-15 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202860-001 | 11291793 | 2025-08-18 | Drug product | 2022-05-05 | 6a471c1ec25d… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| GENOSYL | NITRIC OXIDE | VERO BIOTECH, INC. | c9560c54-9e28-4039-a4e5-5000c41c6c85 | 2025-12-11 | Warnings, Adverse reactions | 202860 NDA202860 72385-001 |
| GENOSYL | NITRIC OXIDE | VERO BIOTECH, INC. | 8e6b2a92-7915-4709-9076-3a591bf195eb | 2025-12-04 | Warnings, Adverse reactions | 202860 NDA202860 72385-002 |
| GENOSYL | NITRIC OXIDE | VERO BIOTECH, INC. | be87cfcb-8cee-4a36-96a5-1b79ef5652bb | 2025-12-04 | Warnings, Adverse reactions | 202860 NDA202860 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 72385-001 | GENOSYL | nitric oxide | VERO BIOTECH, INC. | NDA | Current |
| 72385-001 | GENOSYL | nitric oxide | VERO BIOTECH LLC | NDA | Current |
| 72385-001 | GENOSYL | nitric oxide | VERO BIOTECH LLC | NDA | Current |
| 72385-001 | GENOSYL | nitric oxide | VERO BIOTECH LLC | NDA | Current |
| 72385-001 | GENOSYL | nitric oxide | VERO BIOTECH LLC | NDA | Current |
| 72385-002 | GENOSYL | nitric oxide | VERO BIOTECH, INC. | NDA | Current |