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United States · US · US:51862-047_129c30f2-85d6-59ee-e063-6294a90aef97
Amethia
Orange BookSPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMayne Pharma 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
A078834
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"d6a33ea7-ecd1-4f81-a984-f210a3989618": {
"match": "brand_token",
"title": "AMETHIA (ETHINYL ESTRADIOL AND LEVONORGESTREL) KIT [MAYNE PHARMA INC]",
"spl_version": "7",
"published_date": "2024-03-04"
}
},
"productid": "51862-047_129c30f2-85d6-59ee-e063-6294a90aef97",
"productndc": "51862-047",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "078834",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "0.03MG,0.01MG;0.15MG,N/A",
"product_no": "001",
"approval_date": "May 31, 2011"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "Amethia",
"active_ingred_unit": null,
"application_number": "ANDA078834",
"marketing_category": "ANDA",
"nonproprietary_name": "ETHINYL ESTRADIOL and LEVONORGESTREL",
"start_marketing_date": "20161012",
"active_numerator_strength": null
}Access this data programmatically
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