Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Cipla USA Inc.
078719707
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
LSNE-LEON SLU
Cipla USA Inc.
Cipla USA Inc.
464038373
Aspen Oss B.V.
Cipla USA Inc.
Cipla USA Inc.
491013870
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
69097-537Application Number
ANDA210362Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
August 30, 2023BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 200 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACTQuantity: 0.2 mL in 1 mL
COTTON SEEDInactive
Code: DI0ZRJ0MXNClass: IACTQuantity: 560 mg in 1 mL
TESTOSTERONE CYPIONATE
Product Details
NDC Product Code
69097-536Application Number
ANDA210362Marketing Category
ANDA (C73584)Route of Administration
INTRAMUSCULAREffective Date
August 30, 2023Testosterone cypionateActive
Code: M0XW1UBI14Class: ACTIBQuantity: 100 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
COTTON SEEDInactive
Code: DI0ZRJ0MXNClass: IACTQuantity: 736 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACTQuantity: 0.1 mL in 1 mL