Ultramicrosize Griseofulvin
ULTRAMICROSIZE GRISEOFULVIN TABLETS USP
Approved
Approval ID
efb8a660-802c-4ca6-bbff-ad7b48b91aef
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Chartwell RX, LLC.
DUNS: 079394054
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 Code62135-495
Application NumberANDA061996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (6)
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GRISEOFULVINActive
Quantity: 250 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
Griseofulvin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62135-494
Application NumberANDA061996
Product Classification
M
Marketing Category
C73584
G
Generic Name
Griseofulvin
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (6)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
GRISEOFULVINActive
Quantity: 125 mg in 1 1
Code: 32HRV3E3D5
Classification: ACTIB