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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0713-0850
Application NumberANDA065438
Product Classification
M
Marketing Category
C73584
G
Generic Name
Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
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