Tri-VyLibra Lo
These highlights do not include all the information needed to use TRI-VYLIBRA LO safely and effectively. See full prescribing information for TRI-VYLIBRA LO. Tri-VyLibra Lo (norgestimate and ethinyl estradiol) tablets for oral use Initial U.S. Approval: 1989
Approved
Approval ID
bd51a08e-cd45-4315-9bca-41794450ef16
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 4, 2023
Manufacturers
FDA
Afaxys Pharma, LLC
DUNS: 080508656
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Norgestimate and Ethinyl Estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50102-231
Application NumberANDA205762
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norgestimate and Ethinyl Estradiol
Product Specifications
Effective DateMay 4, 2023
FDA Product Classification