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United States · US · US:65862-887_e3758444-132a-4c4d-b713-cc5f3b990288

Kalliga

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
    6586288788
    3 POUCH in 1 CARTON (65862-887-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK
  • ndc11
    6586288792
    6 POUCH in 1 CARTON (65862-887-92) / 1 BLISTER PACK in 1 POUCH (65862-887-28) / 1 KIT in 1 BLISTER PACK

Annotations

Orange Book
A207081
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "route": null,
  "spl_meta": {
    "dbe9f9ab-2e38-49e3-bb1f-c8a12d03076a": {
      "match": "brand_token",
      "title": "KALLIGA (DESOGESTREL AND ETHINYL ESTRADIOL) KIT [AUROBINDO PHARMA LIMITED]",
      "spl_version": "8",
      "published_date": "2024-11-05"
    }
  },
  "productid": "65862-887_e3758444-132a-4c4d-b713-cc5f3b990288",
  "productndc": "65862-887",
  "dosage_form": "KIT",
  "orange_book": {
    "appl_no": "207081",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.15MG;0.03MG",
        "product_no": "001",
        "approval_date": "May 17, 2017"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": null,
  "proprietary_name": "Kalliga",
  "active_ingred_unit": null,
  "application_number": "ANDA207081",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Desogestrel and Ethinyl Estradiol",
  "start_marketing_date": "20170517",
  "active_numerator_strength": null
}

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