Balcoltra
These highlights do not include all the information needed to use BALCOLTRA safely and effectively. See Full Prescribing Information for BALCOLTRA. Initial U.S. Approval: 1997
Approved
Approval ID
752ab698-4b48-4614-8016-d1d33ee7c007
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Avion Pharmaceuticals
DUNS: 040348516
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
levonorgestrel and ethinyl estradiol
PRODUCT DETAILS
NDC Product Code75854-602
Application NumberNDA208612
Marketing CategoryC73594
Route of AdministrationN/A
Effective DateApril 1, 2022
Generic Namelevonorgestrel and ethinyl estradiol