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FDA Approval

HYFTOR

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

FDA Approval Summary

Company
Effective Date
January 11, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Sirolimus(2 mg in 1 g)

Manufacturing Establishments2

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

Sharp Clinical, Inc

Nobelpharma America, LLC

079209266

Toyo Pharmaceutical Co., Ltd.

Nobelpharma America, LLC

717792357

Products1

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

HYFTOR

Product Details

NDC Product Code
73683-101
Application Number
NDA213478
Marketing Category
NDA (C73594)
Route of Administration
TOPICAL
Effective Date
January 11, 2024
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27EClass: IACT
ALCOHOLInactive
Code: 3K9958V90MClass: IACT
TROLAMINEInactive
Code: 9O3K93S3TKClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SirolimusActive
Code: W36ZG6FT64Class: ACTIBQuantity: 2 mg in 1 g
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