Tri-Lo-Sprintec
These highlights do not include all the information needed to use TRI-LO-SPRINTEC safely and effectively. See full prescribing information for TRI-LO-SPRINTEC.TRI-LO-SPRINTEC (norgestimate/ethinyl estradiol) tablets for oral useInitial U.S. Approval: 1989
Approved
Approval ID
9f96a0fb-21e2-40af-a33c-cf0984fe2550
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2023
Manufacturers
FDA
Preferred Pharmaceuticals Inc.
DUNS: 791119022
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 Code68788-7036
Application NumberANDA076784
Product Classification
M
Marketing Category
C73584
G
Generic Name
Norgestimate and Ethinyl Estradiol
Product Specifications
Effective DateOctober 4, 2023
FDA Product Classification