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FDA Approval

Priftin

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

FDA Approval Summary

Company
Effective Date
January 8, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Rifapentine(150 mg in 1 1)

Manufacturing Establishments1

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

A-S Medication Solutions

A-S Medication Solutions

830016429

Products1

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

Priftin

Product Details

NDC Product Code
50090-5063
Application Number
NDA021024
Marketing Category
NDA (C73594)
Route of Administration
ORAL
Effective Date
July 6, 2018
CALCIUM STEARATEInactive
Code: 776XM7047LClass: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86KClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Code: XJM390A33UClass: ACTIBQuantity: 150 mg in 1 1
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
HYDROXYPROPYL CELLULOSE (1600000 WAMW)Inactive
Code: RFW2ET671PClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
SODIUM ASCORBATEInactive
Code: S033EH8359Class: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM STARCH GLYCOLATE TYPE A CORNInactive
Code: AG9B65PV6BClass: IACT
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