Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 206441
Company: PADAGIS ISRAEL

Products on ANDA 206441

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
DESOXIMETASONE	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 206441

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2017	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/23/2023	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 206441

DESOXIMETASONE

SPRAY;TOPICAL; 0.25%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
DESOXIMETASONE	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	No	AT	208124	LUPIN
DESOXIMETASONE	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	No	AT	206441	PADAGIS ISRAEL
TOPICORT	DESOXIMETASONE	0.25%	SPRAY;TOPICAL	Prescription	Yes	AT	204141	TARO