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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
}

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