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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
July 7, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Testosterone cypionate(200 mg in 1 mL)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Hikma Pharmaceuticals USA Inc.

001230762

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
0143-9005
Application Number
ANDA091244
Marketing Category
ANDA (C73584)
Route of Administration
INTRAMUSCULAR
Effective Date
July 7, 2021
Code: M0XW1UBI14Class: ACTIBQuantity: 200 mg in 1 mL
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACTQuantity: 9.45 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
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