JBA Omelia
Approved
Approval ID
ae63fe31-f602-4171-abed-a7212864d064
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Mar 31, 2025
Manufacturers
FDA
Advanced Pharmaceutical Services, Inc. Dba Affordable Quality Pharmaceuticals
DUNS: 187498279
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sea Buckthorn extract,Maca (Lepidium meyenii) extract,Tongkat Ali (Eurycoma longifolia) Peptides
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13411-857
Product Classification
G
Generic Name
Sea Buckthorn extract,Maca (Lepidium meyenii) extract,Tongkat Ali (Eurycoma longifolia) Peptides
Product Specifications
Route of AdministrationORAL
Effective DateMarch 31, 2025
FDA Product Classification
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HIPPOPHAE RHAMNOIDES WHOLEActive
Quantity: 380 mg in 1 1
Code: YAA7TG74X6
Classification: ACTIB
LEPIDIUM MEYENII ROOTActive
Quantity: 120 mg in 1 1
Code: HP7119212T
Classification: ACTIB
EURYCOMA LONGIFOLIA ROOTActive
Quantity: 20 mg in 1 1
Code: 43B8E2HG8B
Classification: ACTIB