Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Bryant Ranch Prepack
171714327
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Bryant Ranch Prepack
Bryant Ranch Prepack
Bryant Ranch Prepack
171714327
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Proctosol-HC
Product Details
NDC Product Code
72162-2165Application Number
ANDA088799Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
December 8, 2023LANOLIN OILInactive
Code: OVV5IIJ58FClass: IACT
HydrocortisoneActive
Code: WI4X0X7BPJClass: ACTIBQuantity: 25 mg in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
PROPYLENE GLYCOL MONOPALMITOSTEARATEInactive
Code: F76354LMGRClass: IACT
MINERAL OILInactive
Code: T5L8T28FGPClass: IACT
ISOPROPYL PALMITATEInactive
Code: 8CRQ2TH63MClass: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4MClass: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCNClass: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58XClass: IACT
POLYOXYL 40 STEARATEInactive
Code: 13A4J4NH9IClass: IACT
SORBIC ACIDInactive
Code: X045WJ989BClass: IACT
METHYLPARABENInactive
Code: A2I8C7HI9TClass: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OHClass: IACT