Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078305
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION;TOPICAL Prescription AT No No
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

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 077579 AKORN
CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION;TOPICAL Prescription No AT 078468 COSETTE
CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION;TOPICAL Prescription No AT 078305 FOUGERA PHARMS
CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION;TOPICAL Prescription No AT 207163 NOVEL LABS INC
CALCIPOTRIENE CALCIPOTRIENE 0.005% SOLUTION;TOPICAL Prescription No AT 077029 TOLMAR

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