Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021152
Company: FOUGERA PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CUTIVATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription AB Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
03/31/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Letter (PDF)
Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021152ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021152s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2014 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

04/01/2013 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/24/2013 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

05/12/2011 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021152s005ltr.pdf
01/16/2015 SUPPL-4 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021152Orig1s004ltr.pdf
12/19/2014 SUPPL-3 Labeling-Container/Carton Labels, Labeling-Package Insert

Label is not available on this site.

09/03/2010 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021152s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/16/2015 SUPPL-4 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf
05/12/2011 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf
09/03/2010 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf

CUTIVATE

LOTION;TOPICAL; 0.05%
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CUTIVATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription Yes AB 021152 FOUGERA PHARMS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 090759 GLENMARK GENERICS
FLUTICASONE PROPIONATE FLUTICASONE PROPIONATE 0.05% LOTION;TOPICAL Prescription No AB 091553 PERRIGO ISRAEL

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