Griseofulvin
GRISEOFULVIN TABLETS, USP (MICROSIZE) Rx Only
Approved
Approval ID
5bafb97f-621b-4b96-a787-68e0bb5c8637
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2022
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
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 Code42794-012
Application NumberANDA202482
Product Classification
M
Marketing Category
C73584
G
Generic Name
Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2022
FDA Product Classification
INGREDIENTS (9)
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
GRISEOFULVINActive
Quantity: 500 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT