Montelukast sodium
Montelukast Sodium is a prescription medication available as oral granules, each packet containing 4 mg of the active ingredient. Manufactured by Aurobindo Pharma Limited, it acts as a leukotriene receptor antagonist to help manage symptoms of asthma and allergic rhinitis. Packaged in cartons of 30 packets, it's approved under ANDA213471. This information was generated using AI and is provided for informational and research purposes only.
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Complete Metadata
| @type | dcat:Dataset |
|---|---|
| accessLevel | public |
| accrualPeriodicity | R/P1Y |
| bureauCode |
[
"009:10"
]
|
| contactPoint |
{
"fn": "Division of Drug Information",
"@type": "vcard:Contact",
"hasEmail": "mailto:druginfo@fda.hhs.gov"
}
|
| description | Montelukast Sodium is a prescription medication available as oral granules, each packet containing 4 mg of the active ingredient. Manufactured by Aurobindo Pharma Limited, it acts as a leukotriene receptor antagonist to help manage symptoms of asthma and allergic rhinitis. Packaged in cartons of 30 packets, it's approved under ANDA213471. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Montelukast sodium",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Montelukast sodium — ANDA 201581 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=201581"
}
]
|
| identifier | ANDA201581 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-information",
"drug-manufacturers",
"fda",
"health-care"
]
|
| landingPage | https://www.fda.gov/drugs |
| license | https://open.fda.gov/license |
| modified | 2025-03-17 |
| programCode |
[
"009:002"
]
|
| publisher |
{
"name": "U.S. Food and Drug Administration",
"@type": "org:Organization"
}
|
| theme |
[
"FDA"
]
|
| title | Montelukast sodium |
