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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
Asclemed USA, Inc.
DUNS: 059888437
Effective Date
November 20, 2023
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.

ASCLEMED USA INC. DBA ENOVACHEM

Asclemed USA, Inc.

059888437

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
76420-645
Application Number
ANDA040530
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
November 20, 2023
BENZYL BENZOATEInactive
Code: N863NB338GClass: IACT
COTTONSEED OILInactive
Code: H3E878020NClass: IACT
Code: M0XW1UBI14Class: ACTIBQuantity: 200 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
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