Details for New Drug Application (NDA): 203144
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NDA 203144 describes ULSPIRA, which is a drug marketed by Airgas Therap and is included in one NDA. It is available from one supplier. Additional details are available on the ULSPIRA profile page.
The generic ingredient in ULSPIRA 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 ULSPIRA 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 203144
| Tradename: | ULSPIRA |
| Applicant: | Airgas Therap |
| Ingredient: | nitric oxide |
| Patents: | 0 |
Pharmacology for NDA: 203144
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 203144
Suppliers and Packaging for NDA: 203144
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ULSPIRA | nitric oxide | GAS;INHALATION | 203144 | ANDA | Airgas Therapeutics, LLC | 82605-006 | 82605-006-01 | 2138 L in 1 CYLINDER (82605-006-01) |
| ULSPIRA | nitric oxide | GAS;INHALATION | 203144 | ANDA | Airgas Therapeutics, LLC | 82605-006 | 82605-006-02 | 362 L in 1 CYLINDER (82605-006-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | GAS;INHALATION | Strength | 800PPM | ||||
| Approval Date: | Jul 27, 2023 | TE: | AA | RLD: | No | ||||
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