Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019452
Company: HILL DERMAC
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. |
||
| 08/30/2024 | SUPPL-27 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/019452s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/019452Orig1s027ltr.pdf | |
| 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.html | |
| 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.html | |
| 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 |
|---|---|---|---|---|---|
| 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 |
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 |
| 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 | 090982 | RISING |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 203377 | RISING |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202368 | SUN PHARMA CANADA |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 209336 | SUN PHARMA CANADA |
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 |
| 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 | 090982 | RISING |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 203377 | RISING |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 202368 | SUN PHARMA CANADA |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL;TOPICAL | Prescription | No | AT | 209336 | SUN PHARMA CANADA |
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 | 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 | 203378 | RISING |
| FLUOCINOLONE ACETONIDE | FLUOCINOLONE ACETONIDE | 0.01% | OIL/DROPS;OTIC | Prescription | No | AT | 213264 | TP ANDA HOLDINGS |