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Testosterone Cypionate

Testosterone Cypionate Injection, USP CIII Rx Only

Approved
Approval ID

54aee197-7c9c-479f-8a4d-a8d4d31f40c1

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2023

Manufacturers
FDA

Asclemed USA, Inc.

DUNS: 059888437

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Testosterone Cypionate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76420-645
Application NumberANDA040530
Product Classification
M
Marketing Category
C73584
G
Generic Name
Testosterone Cypionate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateNovember 20, 2023
FDA Product Classification

INGREDIENTS (4)

BENZYL BENZOATEInactive
Code: N863NB338G
Classification: IACT
COTTONSEED OILInactive
Code: H3E878020N
Classification: IACT
TESTOSTERONE CYPIONATEActive
Quantity: 200 mg in 1 mL
Code: M0XW1UBI14
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT

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Testosterone Cypionate - FDA Drug Approval Details