Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218298
Company: RISING

Products on ANDA 218298

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROCORTISONE	HYDROCORTISONE	2.5%	LOTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218298

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218298

HYDROCORTISONE

LOTION;TOPICAL; 2.5%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCORTISONE	HYDROCORTISONE	2.5%	LOTION;TOPICAL	Prescription	No	AT	218298	RISING
STIE-CORT	HYDROCORTISONE	2.5%	LOTION;TOPICAL	Prescription	No	AT	089074	PADAGIS US