Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Chartwell Pharmaceuticals Congers, LLC.
Chartwell RX, LLC.
118673447
Products2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ultramicrosize Griseofulvin
Product Details
NDC Product Code
62135-495Application Number
ANDA061996Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 5, 2023SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GriseofulvinActive
Code: 32HRV3E3D5Class: ACTIBQuantity: 250 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
Ultramicrosize Griseofulvin
Product Details
NDC Product Code
62135-494Application Number
ANDA061996Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 5, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GriseofulvinActive
Code: 32HRV3E3D5Class: ACTIBQuantity: 125 mg in 1 1