PRECISION DERMAT Application 018652

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LOCOID	HYDROCORTISONE BUTYRATE	OINTMENT;TOPICAL	0.1%	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68682-271	Hydrocortisone Butyrate	hydrocortisone butyrate	Oceanside Pharmaceuticals	NDA	Current
68682-271	Hydrocortisone Butyrate	hydrocortisone butyrate	Oceanside Pharmaceuticals	NDA	Current
68682-271	Hydrocortisone Butyrate	hydrocortisone butyrate	Oceanside Pharmaceuticals	NDA	Current

Document, Submission type, Date table
Document	Submission type	Date
11261	SUPPL	2014-11-04
996	SUPPL	2014-10-31