Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Symbiotec Pharmalab Private Limited
Eugia US LLC
677604336
EUGIA Pharma Specialities Limited
Eugia US LLC
872201704
Products3
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
55150-278Application Number
ANDA211817Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
October 21, 2023Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 2000 mg in 10 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACT
COTTONSEED OILInactive
Code: H3E878020NClass: IACT
Testosterone Cypionate
Product Details
NDC Product Code
55150-276Application Number
ANDA211817Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
October 21, 2023Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 1000 mg in 10 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
COTTONSEED OILInactive
Code: H3E878020NClass: IACT
Testosterone Cypionate
Product Details
NDC Product Code
55150-277Application Number
ANDA211817Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
October 21, 2023Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 200 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACT
COTTONSEED OILInactive
Code: H3E878020NClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT