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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019452
Company: HILL DERMAC

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription AT Yes Yes
DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription AT Yes Yes
DERMOTIC FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription AT Yes Yes

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/30/2024 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019452s027lbl.pdf
01/29/2020 SUPPL-40 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019452Orig1s040lbl.pdf
12/12/2007 SUPPL-24 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019452s024lbl.pdf
11/09/2005 SUPPL-20 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf
11/09/2005 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf
11/09/2005 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf
04/21/2003 SUPPL-18 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19452scp018_dermasmoothe_lbl.pdf
10/10/2001 SUPPL-17 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19452s17lbl.pdf
08/18/1999 SUPPL-15 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19425s15lbl.pdf
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