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FDA Approval

Testosterone Cypionate

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
February 2, 2012
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Testosterone cypionate(100 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Physicians Total Care, Inc.

Physicians Total Care, Inc.

194123980

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
54868-3669
Application Number
ANDA040615
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
February 2, 2012
COTTON SEEDInactive
Code: DI0ZRJ0MXNClass: IACTQuantity: 736 mg in 1 mL
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACTQuantity: 0.1 mL in 1 mL
Code: M0XW1UBI14Class: ACTIBQuantity: 100 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 mg in 1 mL
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