Promethazine hydrochloride
Promethazine Hydrochloride is a prescription medication available as oral tablets in strengths of 12.5 mg, 25 mg, and 50 mg. It belongs to the phenothiazine class and is used to treat allergies, nausea, vomiting, and motion sickness. Manufactured by Amneal Pharmaceuticals, this generic drug is approved under ANDA091179. 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 | Promethazine Hydrochloride is a prescription medication available as oral tablets in strengths of 12.5 mg, 25 mg, and 50 mg. It belongs to the phenothiazine class and is used to treat allergies, nausea, vomiting, and motion sickness. Manufactured by Amneal Pharmaceuticals, this generic drug is approved under ANDA091179. This information was generated using AI and is provided for informational and research purposes only. |
| distribution |
[
{
"@type": "dcat:Distribution",
"title": "Promethazine hydrochloride",
"mediaType": "text/html",
"description": "
Access the FDA dataset for Promethazine hydrochloride — ANDA 083312 submitted by Mylan Institutional LLC
",
"downloadURL": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=083312"
}
]
|
| identifier | ANDA083312 |
| issued | 2016-09-16 |
| keyword |
[
"drug",
"drug-manufacturers",
"health-care",
"medications",
"prescription-drugs"
]
|
| 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 | Promethazine hydrochloride |
