MedPath
FDA Approval

fluconazole

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

FDA Approval Summary

Company
Effective Date
February 6, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Fluconazole(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.

fluconazole

Product Details

NDC Product Code
50090-4425
Application Number
ANDA208963
Marketing Category
ANDA (C73584)
Route of Administration
ORAL
Effective Date
March 21, 2022
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
Code: 8VZV102JFYClass: ACTIBQuantity: 150 mg in 1 1
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
© Copyright 2025. All Rights Reserved by MedPath