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United States · US · US:50458-707_339b28be-aa00-df1a-e063-6294a90a5453
PONVORY
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerJanssen Pharmaceuticals, Inc
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 0
No packs registered.
Annotations
Orange Book
N213498
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"0c025ba8-ba51-272e-e063-6294a90ad120": {
"match": "brand_token",
"title": "PONVORY (PONESIMOD) TABLET, FILM COATED PONVORY (PONESIMOD) KIT [VANDA PHARMACEUTICALS INC.]",
"spl_version": "4",
"published_date": "2025-12-12"
}
},
"productid": "50458-707_339b28be-aa00-df1a-e063-6294a90a5453",
"productndc": "50458-707",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "213498",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "2MG",
"product_no": "001",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "3MG",
"product_no": "002",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "4MG",
"product_no": "003",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "5MG",
"product_no": "004",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "6MG",
"product_no": "005",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "7MG",
"product_no": "006",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "8MG",
"product_no": "007",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "9MG",
"product_no": "008",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "10MG",
"product_no": "009",
"approval_date": "Mar 18, 2021"
},
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "20MG",
"product_no": "010",
"approval_date": "Mar 18, 2021"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "PONVORY",
"active_ingred_unit": null,
"application_number": "NDA213498",
"marketing_category": "NDA",
"nonproprietary_name": "Ponesimod",
"start_marketing_date": "20210318",
"active_numerator_strength": null
}Access this data programmatically
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