Details for New Drug Application (NDA): 207141
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NDA 207141 describes NOXIVENT, which is a drug marketed by Linde Gas Equip and is included in one NDA. It is available from one supplier. Additional details are available on the NOXIVENT profile page.
The generic ingredient in NOXIVENT is nitric oxide. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
The generic ingredient in NOXIVENT is nitric oxide. There are six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the nitric oxide profile page.
Summary for 207141
| Tradename: | NOXIVENT |
| Applicant: | Linde Gas Equip |
| Ingredient: | nitric oxide |
| Patents: | 0 |
Pharmacology for NDA: 207141
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 207141
Suppliers and Packaging for NDA: 207141
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| NOXIVENT | nitric oxide | GAS;INHALATION | 207141 | ANDA | Linde Gas & Equipment Inc | 59579-101 | 59579-101-01 | 2082 L in 1 CYLINDER (59579-101-01) |
| NOXIVENT | nitric oxide | GAS;INHALATION | 207141 | ANDA | Linde Gas & Equipment Inc | 59579-101 | 59579-101-02 | 323 L in 1 CYLINDER (59579-101-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GAS;INHALATION | Strength | 100PPM | ||||
| Approval Date: | Oct 2, 2018 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | GAS;INHALATION | Strength | 800PPM | ||||
| Approval Date: | Oct 2, 2018 | TE: | AA | RLD: | No | ||||
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