Griseofulvin
Griseofulvin Tablets, USP (MICROSIZE) 250 mg and 500 mg
Approved
Approval ID
98829d90-b289-4bec-a625-7af412a5cb2d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2016
Manufacturers
FDA
Sandoz Inc
DUNS: 005387188
Products 2
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 Code0781-5515
Application NumberANDA091592
Product Classification
M
Marketing Category
C73584
G
Generic Name
Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2016
FDA Product Classification
INGREDIENTS (7)
GRISEOFULVINActive
Quantity: 500 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Griseofulvin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0781-5514
Application NumberANDA091592
Product Classification
M
Marketing Category
C73584
G
Generic Name
Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2016
FDA Product Classification
INGREDIENTS (7)
GRISEOFULVINActive
Quantity: 250 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
CROSPOVIDONE (15 MPA.S AT 5%)Inactive
Code: 68401960MK
Classification: IACT