ACZONE از شرکت ALLERGAN

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داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

ACZONE از شرکت ALLERGAN

New Drug Application (NDA): 021794

Company: ALLERGAN

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ACZONE DAPSONE 5% GEL;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
07/07/2005 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021794ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021794s000TOC.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/18/2018 SUPPL-16 Labeling-Patient Package Insert, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021794Orig1s016ltr.pdf

09/03/2015 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

07/09/2015 SUPPL-13 Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021794Orig1s013ltr.pdf

11/08/2013 SUPPL-12 Labeling-Container/Carton Labels

Label is not available on this site.

10/03/2013 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/31/2013 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/26/2009 SUPPL-6 Labeling-Package Insert, Labeling-Container/Carton Labels

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf

03/14/2008 SUPPL-5 Efficacy-Labeling Change With Clinical Data

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021794s005ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/18/2018 SUPPL-16

Labeling-Patient Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf
05/18/2018 SUPPL-16

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021794s016lbl.pdf
07/09/2015 SUPPL-13

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021794s013lbl.pdf
03/26/2009 SUPPL-6

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/26/2009 SUPPL-6

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021794s006lbl.pdf
03/14/2008 SUPPL-5

Efficacy-Labeling Change With Clinical Data

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021794s005lbl.pdf
07/07/2005 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021794lbl.pdf

ACZONE

GEL;TOPICAL; 5%

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ACZONE DAPSONE 5% GEL;TOPICAL Prescription Yes AB 021794 ALLERGAN
DAPSONE DAPSONE 5% GEL;TOPICAL Prescription No AB 209506 TARO
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