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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210639
Company: XIROMED

Products on ANDA 210639

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 210639

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/18/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 210639

BETAMETHASONE VALERATE

AEROSOL, FOAM;TOPICAL; 0.12%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	078337	PADAGIS ISRAEL
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	208204	TARO
BETAMETHASONE VALERATE	BETAMETHASONE VALERATE	0.12%	AEROSOL, FOAM;TOPICAL	Prescription	No	AB	210639	XIROMED

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