Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
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
63629-9134Application Number
ANDA078423Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
March 25, 2021CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 100 mg in 1 1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POVIDONE K30Inactive
Code: U725QWY32XClass: IACT