Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 200174
Company: PADAGIS ISRAEL

Products on ANDA 200174

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	OINTMENT;TOPICAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 200174

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/12/2014	ORIG-1	Approval	Not Applicable		Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200174Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 200174

CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE

OINTMENT;TOPICAL; 0.064%;0.005%
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	OINTMENT;TOPICAL	Prescription	No	AB	200174	PADAGIS ISRAEL
TACLONEX	BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE	0.064%;0.005%	OINTMENT;TOPICAL	Prescription	Yes	AB	021852	LEO PHARMA AS