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United States · US · US:65862-886_1dd39b93-a209-4ebb-a559-1fe137e66972

SIMLIYA

Orange BookSPL

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerAurobindo Pharma Limited
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6586288688
    3 POUCH in 1 CARTON (65862-886-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586288692
    6 POUCH in 1 CARTON (65862-886-92) / 1 BLISTER PACK in 1 POUCH (65862-886-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A206853
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "4161f614-6e55-4114-87f7-19bb77f6b09b": {
      "match": "brand_token",
      "title": "SIMLIYA (DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "11",
      "published_date": "2024-10-23"
    }
  },
  "productid": "65862-886_1dd39b93-a209-4ebb-a559-1fe137e66972",
  "productndc": "65862-886",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206853",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG,N/A;0.02MG,0.01MG",
        "product_no": "001",
        "approval_date": "Mar 22, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "SIMLIYA",
  "active_ingred_unit": null,
  "application_number": "ANDA206853",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desogestrel and Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20170322",
  "active_numerator_strength": null
}

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