Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 209556
Company: THE J MOLNER

Products on ANDA 209556

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	LOTION;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 209556

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/21/2017	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209556Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2024	SUPPL-4	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 209556

HYDROCORTISONE BUTYRATE

LOTION;TOPICAL; 0.1%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	LOTION;TOPICAL	Prescription	No	AB	210209	LUPIN LTD
HYDROCORTISONE BUTYRATE	HYDROCORTISONE BUTYRATE	0.1%	LOTION;TOPICAL	Prescription	No	AB	209556	THE J MOLNER