SULFADIAZINE
sulfADIAZINE Tablets, USP
Approved
Approval ID
8993651b-fff6-4e3f-9b60-78587bc9bcee
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 8, 2023
Manufacturers
FDA
EPIC PHARMA, LLC
DUNS: 827915443
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sulfadiazine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-757
Application NumberANDA040091
Product Classification
M
Marketing Category
C73584
G
Generic Name
sulfadiazine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2021
FDA Product Classification
INGREDIENTS (8)
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SULFADIAZINEActive
Quantity: 500 mg in 1 1
Code: 0N7609K889
Classification: ACTIB