Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Hainan Poly Pharm. Co., Ltd.
654561638
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Zhejiang Poly Pharm. Co., Ltd.
Slate Run Pharmaceuticals
Hainan Poly Pharm. Co., Ltd.
421336452
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
70436-227Application Number
ANDA215738Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 24, 2024SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
FluconazoleActive
Code: 8VZV102JFYClass: ACTIBQuantity: 40 mg in 1 mL