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United States · US · US:51862-545_3aadfd82-3d97-6e99-e063-6294a90a958e
SRONYX
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
A077681
AB2
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"route": null,
"spl_meta": {
"b0c1a495-4cd7-4664-8fe4-714812f53c71": {
"match": "brand_token",
"title": "SRONYX (LEVONORGESTREL AND ETHINYL ESTRADIOL) KIT [MAYNE PHARMA INC.]",
"spl_version": "8",
"published_date": "2025-07-28"
}
},
"productid": "51862-545_3aadfd82-3d97-6e99-e063-6294a90a958e",
"productndc": "51862-545",
"dosage_form": "KIT",
"orange_book": {
"appl_no": "077681",
"products": [
{
"rs": true,
"rld": false,
"te_code": "AB2",
"strength": "0.02MG;0.1MG",
"product_no": "001",
"approval_date": "May 31, 2006"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": null,
"proprietary_name": "SRONYX",
"active_ingred_unit": null,
"application_number": "ANDA077681",
"marketing_category": "ANDA",
"nonproprietary_name": "Levonorgestrel and Ethinyl Estradiol",
"start_marketing_date": "20160803",
"active_numerator_strength": null
}Access this data programmatically
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