Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Lyne Laboratories, Inc.
Rising Pharma Holdings, Inc.
053510459
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
PROCTOZONE-HC
Product Details
NDC Product Code
64980-324Application Number
ANDA040879Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
June 23, 2023HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7JClass: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJSClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58XClass: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9IClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT