ACZONE از شرکت ALLERGAN

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ACZONE از شرکت ALLERGAN

New Drug Application (NDA): 021794

Company: ALLERGAN

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusTE CodeRLDRS
ACZONEDAPSONE5%GEL;TOPICALPrescription

AB

YesYes
Original Approvals or Tentative Approvals
Action DateSubmissionAction TypeSubmission ClassificationReview Priority; Orphan StatusLetters, Reviews, Labels, Patient Package InsertNotesUrl
07/07/2005ORIG-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels, Patient Package InsertNoteUrl
05/18/2018SUPPL-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

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

Label is not available on this site.

07/09/2015SUPPL-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

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

Label is not available on this site.

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

Label is not available on this site.

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

Label is not available on this site.

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

Label (PDF)

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

03/14/2008SUPPL-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 DateSubmissionSupplement Categories or Approval TypeLetters, Reviews, Labels,
Patient Package Insert
NoteUrl
05/18/2018SUPPL-16

Labeling-Patient Package Insert

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

Labeling-Package Insert

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

Labeling-Package Insert

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

Labeling-Package Insert

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

Labeling-Container/Carton Labels

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

Efficacy-Labeling Change With Clinical Data

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

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

ACZONE

GEL;TOPICAL; 5%

TE Code = AB

Drug NameActive IngredientsStrengthDosage Form/RouteMarketing StatusRLDTE CodeApplication No.Company
ACZONEDAPSONE5%GEL;TOPICALPrescriptionYesAB021794ALLERGAN
DAPSONEDAPSONE5%GEL;TOPICALPrescriptionNoAB209506TARO
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