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Application 202860
- Type
- NDA
- Sponsor
- VERO BIOTECH
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | GENOSYL | NITRIC OXIDE | GAS;INHALATION | 800PPM | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| 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 |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 62040 | ORIG | 2020-03-05 |
| 61443 | ORIG | 2019-12-26 |
| 61405 | ORIG | 2019-12-23 |