Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Aurobindo Pharma Limited
650082092
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Aurobindo Pharma Limited
NorthStar Rx LLC
Aurobindo Pharma Limited
918917642
Products2
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
16714-696Application Number
ANDA079150Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 22, 2024SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 40 mg in 1 mL
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
Fluconazole
Product Details
NDC Product Code
16714-695Application Number
ANDA079150Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 22, 2024FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 10 mg in 1 mL
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT