Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
HIKMA FARMACEUTICA (PORTUGAL), S.A
Hikma Pharmaceuticals USA Inc.
452742943
Products2
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
0143-9659Application Number
ANDA091244Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
March 14, 2022Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 200 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
COTTONSEED OILInactive
Code: H3E878020NClass: IACTQuantity: 560 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACTQuantity: 0.2 mL in 1 mL
Testosterone Cypionate
Product Details
NDC Product Code
0143-9726Application Number
ANDA091244Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
March 14, 2022Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 200 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
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL