LoJaimiess
These highlights do not include all the information needed to use LoJaimiess safely and effectively. See full prescribing information for LoJaimiess. LoJaimiess® Levonorgestrel and Ethinyl Estradiol Tablets,USP and Ethinyl Estradiol Tablets, USP 0.1 mg/0.02 mg, and 0.01 mg for oral use Initial U.S. Approval: 1982
Approved
Approval ID
5f0b397c-256a-0163-35c7-e9401705b439
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 25, 2023
Manufacturers
FDA
Xiromed, LLC.
DUNS: 080228637
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levonorgestrel/ethinyl estradiol and ethinyl estradiol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70700-124
Application NumberANDA205131
Product Classification
M
Marketing Category
C73584
G
Generic Name
levonorgestrel/ethinyl estradiol and ethinyl estradiol
Product Specifications
Effective DateJune 8, 2022
FDA Product Classification