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FDA Approval

Hexatrione

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

FDA Approval Summary

Company
Medexus Pharma, Inc.
DUNS: 078811131
Effective Date
January 10, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Triamcinolone(40 mg in 2 mL)

Manufacturing Establishments1

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

Valdepharm

Medexus Pharma, Inc.

260128560

Products1

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

Hexatrione 2%

Product Details

NDC Product Code
59137-570
Route of Administration
INTRA-ARTICULAR
Effective Date
January 10, 2023
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBHClass: IACT
SORBITOL SOLUTION 70%Inactive
Code: 8KW3E207O2Class: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
Code: I7GT1U99Y9Class: ACTIBQuantity: 40 mg in 2 mL
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

HEALTH CARE PROVIDER LETTER SECTION

DHCP_01DHCP_02DHCP_03DHCP_04DHCP_05DHCP_06DHCP_07DHCP_08DHCP_09DHCP_10DHCP_11DHCP_12DHCP_13DHCP_14DHCP_15DHCP_16DHCP_17DHCP_18DHCP_19DHCP_20DHCP_21DHCP_22DHCP_23DHCP_24DHCP_25DHCP_26


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