Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078305
Company: FOUGERA PHARMS

Products on ANDA 078305

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	AT	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078305

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/06/2008	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078305s000ltr.pdf

Therapeutic Equivalents for ANDA 078305

CALCIPOTRIENE

SOLUTION;TOPICAL; 0.005%
TE Code = AT

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	No	AT	207163	CHARTWELL RX
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	No	AT	078468	COSETTE
CALCIPOTRIENE	CALCIPOTRIENE	0.005%	SOLUTION;TOPICAL	Prescription	No	AT	078305	FOUGERA PHARMS