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Details for New Drug Application (NDA): 202860
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NDA 202860 describes GENOSYL, which is a drug marketed by Vero Biotech and is included in one NDA. It is available from one supplier. Additional details are available on the GENOSYL profile page.
The generic ingredient in GENOSYL is nitric oxide. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
The generic ingredient in GENOSYL is nitric oxide. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
Summary for 202860
| Tradename: | GENOSYL |
| Applicant: | Vero Biotech |
| Ingredient: | nitric oxide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 202860
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 202860
Suppliers and Packaging for NDA: 202860
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GENOSYL | nitric oxide | GAS;INHALATION | 202860 | NDA | VERO BIOTECH LLC | 72385-001 | 72385-001-01 | 216 L in 1 CARTRIDGE (72385-001-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GAS;INHALATION | Strength | 800PPM | ||||
| Approval Date: | Dec 20, 2019 | TE: | RLD: | Yes | |||||
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