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Testosterone Cypionate

Testosterone Cypionate Injection, USP

Approved
Approval ID

108facca-c6d2-48fa-ba48-667c9498c61b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 3, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

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 Code54868-3618
Application NumberANDA040530
Product Classification
M
Marketing Category
C73584
G
Generic Name
Testosterone Cypionate
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJanuary 3, 2012
FDA Product Classification

INGREDIENTS (4)

Testosterone CypionateActive
Quantity: 200 mg in 1 mL
Code: M0XW1UBI14
Classification: ACTIM
Benzyl BenzoateInactive
Quantity: 0.2 mL in 1 mL
Code: N863NB338G
Classification: IACT
Cotton SeedInactive
Quantity: 560 mg in 1 mL
Code: DI0ZRJ0MXN
Classification: IACT
Benzyl AlcoholInactive
Quantity: 9.45 mg in 1 mL
Code: LKG8494WBH
Classification: IACT

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Testosterone Cypionate - FDA Drug Approval Details