Sulfadiazine
sulfADIAZINE Tablets, USP
Approved
Approval ID
10549cba-9c15-4d2e-a68c-5afbc178591d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2020
Manufacturers
FDA
Eon Labs, Inc.
DUNS: 012656273
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulfadiazine
PRODUCT DETAILS
NDC Product Code0185-0757
Application NumberANDA040091
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 30, 2020
Generic NameSulfadiazine
INGREDIENTS (8)
SULFADIAZINEActive
Quantity: 500 mg in 1 1
Code: 0N7609K889
Classification: ACTIB
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 STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT