Drugs@FDA: FDA-Approved Drugs
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 |
---|---|---|---|---|---|
01/29/2020 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019452Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019452Orig1s040ltr.pdf | |
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 |
---|---|---|---|---|---|
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 |
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 | 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 | 207345 | NOVEL LABS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 207347 | NOVEL LABS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202847 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202848 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 212760 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 212761 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202368 | TARO PHARMS |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 209336 | TARO PHARMS |
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 | 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 | 207345 | NOVEL LABS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 207347 | NOVEL LABS INC |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202847 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202848 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 212760 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 212761 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202368 | TARO PHARMS |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 209336 | TARO PHARMS |
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 | PATRIN |
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 | PADAGIS ISRAEL |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 212762 | QUAGEN |
FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 213264 | TASMAN PHARMA |
FLUOCINONIDE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 211815 | GLENMARK PHARMS LTD |