Norgestimate and ethinyl estradiol
These highlights do not include all the information needed to use NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP safely and effectively. See full prescribing information for NORGESTIMATE AND ETHINYL ESTRADIOL TABLETS USP. NORGESTIMATE and ETHINYL ESTRADIOL tablets USP, for oral use Initial U.S. Approval: 1989
Approved
Approval ID
b936a6fb-27ed-44de-9199-8c656bcd366e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Naari Pte Limited
DUNS: 659345996
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 Code79929-009
Application NumberANDA200383
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norgestimate and ethinyl estradiol
Product Specifications
Effective DateJanuary 9, 2024
FDA Product Classification