TESTOSTERONE ENANTHATE

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

Company

DUNS: 001230762

Effective Date

November 12, 2021

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Hikma Pharmaceuticals USA Inc.

DUNS Number

452742943

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

NDC Product Code

0143-9750

Application Number

ANDA091120

Marketing Category

ANDA (C73584)

Route of Administration

INTRAMUSCULAR

Effective Date

November 12, 2021

Ingredients

Code: 7Z6522T8N9Class: ACTIBQuantity: 200 mg in 1 mL

CHLOROBUTANOLInactive

Code: HM4YQM8WRCClass: IACTQuantity: 5 mg in 1 mL

SESAME OILInactive

Code: QX10HYY4QVClass: IACT