Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hikma Pharmaceuticals USA Inc.
001230762
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Testosterone Cypionate
Product Details
NDC Product Code
0143-9005Application Number
ANDA091244Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
July 7, 2021Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 200 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACTQuantity: 0.2 mL in 1 mL
COTTONSEED OILInactive
Code: H3E878020NClass: IACTQuantity: 560 mg in 1 mL