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FDA Approval

Depo-Testosterone

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

FDA Approval Summary

Company
Effective Date
February 26, 2010
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Testosterone cypionate(200 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.

Depo-Testosterone

Product Details

NDC Product Code
54868-0216
Application Number
ANDA085635
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
January 12, 2011
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
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