Details for New Drug Application (NDA): 020845
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NDA 020845 describes INOMAX, which is a drug marketed by Mallinckrodt Hosp and is included in one NDA. It is available from one supplier. There are seventeen patents protecting this drug and one Paragraph IV challenge. Additional details are available on the INOMAX profile page.
The generic ingredient in INOMAX 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 INOMAX 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 020845
| Tradename: | INOMAX |
| Applicant: | Mallinckrodt Hosp |
| Ingredient: | nitric oxide |
| Patents: | 17 |
Pharmacology for NDA: 020845
| Physiological Effect | Vasodilation |
Medical Subject Heading (MeSH) Categories for 020845
Suppliers and Packaging for NDA: 020845
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| INOMAX | nitric oxide | GAS;INHALATION | 020845 | NDA | INO THERAPEUTICS LLC | 64693-002 | 64693-002-01 | 1 CYLINDER in 1 CARTON (64693-002-01) / 353 L in 1 CYLINDER |
| INOMAX | nitric oxide | GAS;INHALATION | 020845 | NDA | INO THERAPEUTICS LLC | 64693-002 | 64693-002-02 | 1 CYLINDER in 1 CARTON (64693-002-02) / 1963 L in 1 CYLINDER |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | GAS;INHALATION | Strength | 100PPM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Dec 23, 1999 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 30, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 6, 2031 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Dec 30, 2029 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
Expired US Patents for NDA 020845
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-002 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| Mallinckrodt Hosp | INOMAX | nitric oxide | GAS;INHALATION | 020845-003 | Dec 23, 1999 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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