Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Chartwell Pharmaceuticals Congers, LLC.
Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc
Chartwell Pharmaceuticals Congers, 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
23155-864Application Number
ANDA061996Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 9, 2023MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GriseofulvinActive
Code: 32HRV3E3D5Class: ACTIBQuantity: 250 mg in 1 1
Ultramicrosize Griseofulvin
Product Details
NDC Product Code
23155-863Application Number
ANDA061996Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
August 9, 2023STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3BClass: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
GriseofulvinActive
Code: 32HRV3E3D5Class: ACTIBQuantity: 125 mg in 1 1