Griseofulvin
GRISEOFULVIN ORAL SUSPENSION, USP Microsize 125 mg/5 mL Rx only
Approved
Approval ID
67e3ba3c-77e1-43b5-a93c-5bf5e3855780
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Cosette Pharmaceuticals, Inc.
DUNS: 116918230
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Griseofulvin
PRODUCT DETAILS
NDC Product Code0713-0850
Application NumberANDA065438
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 27, 2023
Generic NameGriseofulvin
INGREDIENTS (20)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUMInactive
Code: K679OBS311
Classification: IACT
SORBIC ACIDInactive
Code: X045WJ989B
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
GRISEOFULVINActive
Quantity: 125 mg in 5 mL
Code: 32HRV3E3D5
Classification: ACTIB
POTASSIUM PHOSPHATE, UNSPECIFIED FORMInactive
Code: B7862WZ632
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQ
Classification: IACT