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United States · US · US:65862-866_482c2fa6-991f-4987-b343-36652f5b7c3f

Lo Simpesse

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 · 1

  • ndc11
    6586286695
    2 POUCH in 1 CARTON (65862-866-95) / 1 BLISTER PACK in 1 POUCH (65862-866-94) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A206852
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "c33072cf-625d-4b4a-981e-ec049c5d78aa": {
      "match": "brand_token",
      "title": "LO LOESTRIN FE (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [ALLERGAN, INC.]",
      "spl_version": "24",
      "published_date": "2025-03-12"
    }
  },
  "productid": "65862-866_482c2fa6-991f-4987-b343-36652f5b7c3f",
  "productndc": "65862-866",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "206852",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.02MG,0.1MG;0.01MG,N/A",
        "product_no": "001",
        "approval_date": "Apr 28, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Lo Simpesse",
  "active_ingred_unit": null,
  "application_number": "ANDA206852",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol",
  "start_marketing_date": "20170428",
  "active_numerator_strength": null
}

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