VyLibra
These highlights do not include all the information needed to use VyLibra safely and effectively. See full prescribing information for VyLibra. VyLibra (norgestimate and ethinyl estradiol) tablets, for oral use Initial U.S. Approval: 1989
Approved
Approval ID
13bdc226-ecf8-4fd7-aa0e-ec19b6b74fc3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 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 Code50102-235
Application NumberANDA205449
Product Classification
M
Marketing Category
C73584
G
Generic Name
norgestimate and ethinyl estradiol
Product Specifications
Effective DateApril 13, 2023
FDA Product Classification