Ultramicrosize Griseofulvin
Rx Only
Approved
Approval ID
37b4d132-84f1-4394-b468-7e74eeec61eb
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 14, 2022
Manufacturers
FDA
Sigmapharm Laboratories, LLC
DUNS: 556234636
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ultramicrosize Griseofulvin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-013
Application NumberANDA202545
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ultramicrosize Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GRISEOFULVINActive
Quantity: 125 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
Ultramicrosize Griseofulvin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42794-014
Application NumberANDA202545
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ultramicrosize Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 14, 2022
FDA Product Classification
INGREDIENTS (11)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
GRISEOFULVINActive
Quantity: 250 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB