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.
CICLOPIROX
Product Details
NDC Product Code
63629-8622Application Number
ANDA078266Marketing Category
ANDA (C73584)Route of Administration
TOPICALEffective Date
February 22, 2022CiclopiroxActive
Code: 19W019ZDRJClass: ACTIBQuantity: 7.7 mg in 1 g
WATERInactive
Code: 059QF0KO0RClass: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302Class: IACT
OCTYLDODECANOLInactive
Code: 461N1O614YClass: IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: 4Q93RCW27EClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0Class: IACT
PEG/PPG-18/18 DIMETHICONEInactive
Code: 9H0AO7T794Class: IACT