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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 24, 2020
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.

A-S Medication Solutions

A-S Medication Solutions

830016429

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
50090-4921
Application Number
ANDA091244
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
March 26, 2019
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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