Drugs@FDA: FDA Approved Drug Products

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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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
02/03/1988 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/13/2016 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

12/03/2007 SUPPL-25 Labeling-Package Insert

Label is not available on this site.

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)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf
11/09/2005 SUPPL-19 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf
04/21/2003 SUPPL-18 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19452scp018_dermasmoothe_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19452scp018ltr.pdf
10/10/2001 SUPPL-17 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19452s17lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/19452s17ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/19-452S017_DermaSmoothe.cfm
11/09/2005 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019452s016,019,020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019452s016,019,020ltr.pdf
08/18/1999 SUPPL-15 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19425s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19452s15ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19452S15_DermaSmooth.cfm
02/04/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

04/26/1996 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

01/30/1996 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

02/16/1995 SUPPL-10 Efficacy-New Indication

Label is not available on this site.

02/16/1995 SUPPL-9 Labeling

Label is not available on this site.

06/25/1992 SUPPL-8 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1996 SUPPL-7 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

01/10/1990 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

06/27/1989 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/15/1989 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

09/08/1988 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
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

DERMA-SMOOTHE/FS

OIL;TOPICAL; 0.01%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription Yes AT 019452 HILL DERMAC
FLUCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 210556 GLENMARK PHARMS LTD
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 091514 AKORN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 201759 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 201764 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 090982 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 203377 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202847 PERRIGO ISRAEL
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202848 PERRIGO ISRAEL
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202368 TARO
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 209336 TARO
FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 210539 GLENMARK PHARMS LTD

OIL;TOPICAL; 0.01%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DERMA-SMOOTHE/FS FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription Yes AT 019452 HILL DERMAC
FLUCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 210556 GLENMARK PHARMS LTD
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 091514 AKORN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 201759 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 201764 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 090982 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 203377 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202847 PERRIGO ISRAEL
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202848 PERRIGO ISRAEL
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 202368 TARO
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 209336 TARO
FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL;TOPICAL Prescription No AT 210539 GLENMARK PHARMS LTD

DERMOTIC

OIL/DROPS;OTIC; 0.01%
TE Code = AT

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DERMOTIC FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription Yes AT 019452 HILL DERMAC
FLAC FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 210736 ANDA REPOSITORY
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 202705 AKORN
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 091306 IDENTI PHARMS INC
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 203378 LYNE
FLUOCINOLONE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 202849 PERRIGO ISRAEL
FLUOCINONIDE ACETONIDE FLUOCINOLONE ACETONIDE 0.01% OIL/DROPS;OTIC Prescription No AT 211815 GLENMARK PHARMS LTD

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