Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Physicians Total Care, Inc.
Physicians Total Care, Inc.
194123980
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Griseofulvin
Product Details
NDC Product Code
54868-5234Application Number
ANDA062483Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 25, 2010ALCOHOLInactive
Code: 3K9958V90MClass: IACT
GriseofulvinActive
Code: 32HRV3E3D5Class: ACTIBQuantity: 125 mg in 5 mL
FD&C RED NO. 40Inactive
Code: WZB9127XOAClass: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8Class: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NCClass: IACT
MENTHOLInactive
Code: L7T10EIP3AClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
SODIUM ALGINATEInactive
Code: C269C4G2ZQClass: IACT